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Theranica to Present Three Real-World Evidence Studies at AHS Scientific Meeting Highlighting the Impact of the Nerivio® REN Wearable on Migraine Treatment
New studies confirm the clear benefit of early acute treatment, the consistent effectiveness of REN over years, and its clinical benefits in migraine both with and without aura BRIDGEWATER, N.J. and NETANYA, Israel, June 19, 2025 (GLOBE NEWSWIRE) -- Theranica, a pioneer in drug-free neuromodulation treatments for idiopathic pain conditions, today announced the presentation of three new real-world studies at the 2025 American Headache Society (AHS) 67th Annual Scientific Meeting, held in Minneapolis, Minnesota. The posters highlight the safety, efficacy, and versatility of the company's prescribed, FDA-cleared Nerivio® REN wearable, the first-and-only remote electrical neuromodulation (REN) therapy indicated for both acute and preventive treatment of migraine in people aged 8 and older. Among the highlights is a long-term study demonstrating that the REN wearable maintains consistent efficacy for migraine treatment over three years of use, with no signs of tachyphylaxis or 'treatment fatigue.' Throughout the study period, patients experienced consistent Pain Relief, Functional Recovery (see Figure), and freedom from migraine-associated symptoms such as photophobia, phonophobia, and nausea/vomiting.'These findings speak to a critical need in migraine treatment: durability with continued use,' said Stephanie J. Nahas, MD, MSEd, FAHS, FAAN, Assistant Director, Headache Medicine Fellowship Program, Jefferson Headache Center and Professor, Department of Neurology, Thomas Jefferson University. 'Migraine disease is complex and non-curable, yet too often patients struggle to find safe, well-tolerated treatments with sustained efficacy over time, something that is necessary to mitigate chronification and maintain quality of life. Seeing ongoing patient adherence with consistent results over a three-year span, without the risk of treatment fatigue, rebound symptoms, or gradually degraded response confirms the REN wearable as a sustainable, non-drug option for the long-term management of a complex condition such as migraine.' Another poster compares REN's impact in treating migraine with and without aura (MWA and MWoA) in nearly 32,000 patients. Despite having more severe baseline symptoms, patients with aura experienced treatment outcomes that were comparable, and in some measures slightly better than in patients without aura. Pain Relief, Functional Recovery, and freedom from migraine-associated symptoms were evident in both groups, reinforcing the REN wearable's reliable performance across these two major migraine subtypes. 'These studies represent some of the most comprehensive real-world analyses to date on the use of REN in migraine treatment. Together, they demonstrate that REN is not only effective when used early for acute treatment—but also durable over time and beneficial across different migraine subtypes,' said Alit Stark-Inbar, Ph.D., VP Medical Information and Research at Theranica. 'Presenting these data at AHS is an excellent vehicle to share clinically meaningful insights with the professional headache community, and to further support physicians in making evidenced-based decisions when taking care of their patients, being well educated about their treatment options'. These recent clinical data reinforce the REN wearable's unique position as a non-drug treatment of migraine, clinically proven to work both acutely and preventively. For patients facing intolerability or lack of efficacy with medications, or seeking non-pharmacological alternatives, Nerivio delivers safe, effective, and non-disruptive relief, without compromising outcomes. As an active participant in this year's AHS 67th Annual Scientific Meeting, held at the Minneapolis Convention Center from June 18 to 22, Theranica reaffirms its commitment to scientific exchange, clinical innovation, and engagement with the broader headache community. AHS remains a cornerstone in advancing migraine intervention and education, and Theranica is proud to contribute meaningful data that help shape the future of the field. Attendees are invited to visit Theranica at booth #501 to learn more. Information can also be found at About NerivioThe Nerivio® REN wearable is an acute and preventive (dual-use) prescription migraine treatment that works without drugs, needles, or invasive procedures. FDA-cleared for patients 8 and above, it uses gentle electrical pulses on the arm to activate the brain's natural pain regulation system, relieving migraine symptoms during an attack, and reducing the frequency and burden of future episodes when used preventively. Controlled by a smartphone app, the Nerivio REN wearable offers a safe, effective, and easy-to-use way to manage migraine—without the risk of systemic side effects or drug interactions. About TheranicaTheranica is a neuromodulation therapeutics company pioneering drug-free treatments for idiopathic pain conditions. Its FDA-cleared flagship product, Nerivio®, is the first-and-only prescribed REN wearable for both acute and preventive migraine care. Used in more than one million treatments across the U.S., Nerivio provides a much-needed option for migraine patient populations with unique qualities, including children, veterans, individuals managing comorbidities, and women of childbearing age. Dedicated to modernizing pain management without drugs or needles, Theranica continues to develop cutting-edge neuromodulation therapies that reshape the way pain is treated. Theranica Contact: Ronen Jashekronenj@ Media Contact:Grey Matter Marketingmedia@ A photo accompanying this announcement is available at: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Lundbeck Advances Leadership in Migraine With New Data at the American Headache Society 67th Annual Scientific Meeting
In a post-hoc analysis of the DELIVER trial, interictal periods were longer with VYEPTI compared to placebo and corresponded to higher patient-reported quality of life outcomes Individuals taking VYEPTI consistently had high, long-term retention rates across studies with anti-CGRP monoclonal antibodies, as seen in a post-hoc analysis across selected phase 3 clinical trials Interim data analysis from the INFUSE study showed most patients surveyed generally had low levels of concern about initiating an intravenous (IV) treatment and reported a positive experience Insights from patient perspectives on migraine symptomology from the anti-PACAP HOPE trial exit interviews support need for comprehensive assessments to better understand the full disease burden, including its cognitive impact DEERFIELD, Ill., June 19, 2025--(BUSINESS WIRE)--Lundbeck US, the US subsidiaries of H. Lundbeck A/S, today announced it will present one oral and eight poster presentations at the 67th Annual Scientific Meeting of the American Headache Society (AHS) in Minneapolis from June 19-22, 2025. The data presentations reinforce the need to look beyond monthly migraine days (MMDs) and the importance of a holistic approach to migraine care as suggested by data from eptinezumab-jjmr post-hoc analyses. VYEPTI® (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below. "Migraine disease affects over 40 million people in the U.S.,1 profoundly impacting every aspect of life for many," said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. "Lundbeck is energized to be at AHS, driving conversations on how we can better understand the holistic burden of migraine and redefine how we approach care. Our focus goes beyond just alleviating individual symptoms—we are committed to improving the overall quality of life for people living with migraine disease." Analyses presented at AHS from several studies including clinical trials and real-world research continue to focus on novel ways to assess VYEPTI and study results and advance preventive migraine care: P-341: Eptinezumab Treatment was Associated with Longer Interictal Periods and Corresponding Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial: Individuals living with migraine who have longer periods of time between migraine attacks (interictal periods) may experience a reduced overall burden of migraine. A post-hoc analysis of the phase 3b DELIVER trial during weeks 1-12 (n=853) and weeks 1-24 (n=832) evaluated the association between the mean longest interictal period and improvements in patient-reported quality of life (QoL) outcomes. Results from this post-hoc analysis indicate the mean longest interictal period was larger with VYEPTI than as reported by patients receiving placebo during the first 24 weeks of the DELIVER trial. Among participants with >14- and >21-day mean longest interictal periods, a greater proportion of participants achieved clinically meaningful improvements in the 6-item Headache Impact test score (HIT-6; ≥5-point total score reduction) and Patient Global Impression of Change (PGIC; "much improved" or "very much improved" rating) with VYEPTI compared with placebo.2 P-333: Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention: Researchers analyzed select phase 3 clinical trials to assess retention rates for adult participants who were treated with VYEPTI and other anti-CGRP mAbs for the prevention of migraine, including long-term eptinezumab trials: the 104-week, open label, single-arm PREVAIL trial and the 72-week DELIVER trial. In this retrospective cohort study of US claims data, VYEPTI showed high, long-term retention rates for preventive treatment in participants with chronic migraine and in those with migraine for whom 2-4 prior migraine preventive treatments have failed, suggesting a high level of participant satisfaction with continued treatment of VYEPTI. Similar results were observed in other anti-CGRP mAbs in this treatment group.3 P-332: Baseline Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive Anti-CGRP Treatment Had Failed: Interim Results of an Ongoing Real-World Study: INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine initiating VYEPTI for the preventive treatment of migraine. In an interim analysis of the first 75 participants entering the INFUSE study, results indicate that individuals, despite having ≥1 prior a-CGRP preventive treatment, reported a long history of disease and high disease burden (with regard to frequency, severity and cognitive impairments). Interim results also showed that the level of concern about initiating an intravenous (IV) treatment was low and participants in the study generally had a positive infusion experience.4 Further highlighting our commitment to pushing the boundaries on migraine care with preventive treatments, Lundbeck also will host a symposium titled, "Why the interictal period matters: Striving for migraine freedom" with Dr. Amaal Starling and Dr. Stewart Tepper on Thursday, June 19 from 12:30 p.m. to 1:15 p.m. CT. "For optimal migraine management, it's important to prioritize continuous improvement and a patient-centered approach," said Dr. Amaal Starling, Neurologist, Mayo Clinic. "These studies highlight the real-world impact of preventive migraine treatments that can provide sustained control, which may allow individuals to focus on their personal goals and live their lives to the fullest." Additional migraine data being presented at AHS include: IOR-02 (Oral): Patient Perspectives of Migraine Symptomology: Insights from Exit Interviews from the anti-PACAP Antibody Phase 2 HOPE Trial for Migraine Prevention5 P-299: Associated Long-Term Clinical Improvements Following ≥50% Migraine Response and Sustained ≥50% and ≥75% Migraine Reductions in Early Responders to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analyses of the DELIVER Trial6 P-320: Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post Hoc Analysis of the Phase 3 PREVAIL Study7 P-319: Impact of Participant-reported ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Results of the REVIEW Real-world Study of Adults With Chronic Migraine Treated with Eptinezumab8 P-297: Eptinezumab and Patient Education in Chronic Migraine and Medication-overuse Headache: Results from the Randomized, Placebo-controlled RESOLUTION Trial9 P-308: Efficacy and Safety of Eptinezumab in Chronic Migraine: A Randomized Placebo-controlled Trial in a Predominantly Asian Population10 About VYEPTI® VYEPTI® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion. The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions. VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. INDICATION VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy. Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. Raynaud's Phenomenon: Development of Raynaud's phenomenon and recurrence or worsening of pre-existing Raynaud's phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. VYEPTI should be discontinued if signs or symptoms of Raynaud's phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud's phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. ADVERSE REACTIONS The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Full Prescribing Information and Patient Information or visit About Migraine DiseaseMigraine is a complex and disabling neurological disease that limits functionality and quality of life.1 It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound.1,11 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.12,13 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.1 It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study. The impact of migraine permeates into career, home life and relationships.14 About INFUSE studyINFUSE is an ongoing, non-interventional, prospective study in individuals with migraine, initiating preventive treatment with eptinezumab-jjmr. Eligible participants were recruited by two infusion center networks and are being followed for 12 months after initiating eptinezumab-jjmr treatment. INFUSE includes adults ≥18 years of age with a diagnosis of migraine who tried ≥1 preventive a-CGRP treatment (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]). About DELIVER studyDELIVER (NCT04418765) is a phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of eptinezumab-jjmr in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes (including: propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan) or botulinum toxin A/B (if documented that botulinum toxin was used for chronic migraine), and at least one failure being due to inadequate efficacy. Patients who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians´ confirmation specific to each treatment in the past 10 years. In the study, 892 patients were randomized to receive eptinezumab-jjmr 100 mg or 300 mg or placebo by IV infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of eptinezumab-jjmr vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, healthcare resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI). The safety and tolerability of eptinezumab-jjmr in the DELIVER study were similar to placebo and consistent with findings from previous eptinezumab-jjmr clinical trials. In DELIVER and earlier eptinezumab-jjmr studies, upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most commonly reported treatment-emergent adverse events (TEAEs). About PREVAIL studyPREVAIL was a phase 3, open-label multi-site U.S.-based study that evaluated eptinezumab-jjmr 300 mg intravenous administration in 128 adults with chronic migraine (CM). PREVAIL included two treatment phases: the primary treatment phase included four infusions of eptinezumab-jjmr 12 weeks apart (Day 0, and Weeks 12, 24, and 36); the secondary treatment phase included up to four additional eptinezumab-jjmr infusions 12 weeks apart (Weeks 48, 60, 72, and 84). Further, patients were followed for 20 additional weeks after the final infusion until Week 104. The PREVAIL study evaluated the long-term safety of repeat doses of eptinezumab-jjmr 300 mg in patients with CM, as well as the pharmacokinetics, immunogenicity, and patient-reported outcomes (PROs). Patient-reported outcome measures included the Migraine Disability Assessment (MIDAS) questionnaire, patient-identified most bothersome symptom (PI-MBS) associated with migraine, Patient Global Impression of Change (PGIC), and 6-item Headache Impact Test (HIT-6). About a-PACAPa-PACAP monoclonal antibody is an investigational compound currently under development (phase 2) for the treatment of migraine. The compound is not commercially available globally. About LundbeckLundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) ("Lundbeck"), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit and connect with us on LinkedIn and X at @LundbeckUS. References 1 Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache, 64(5), 516–532. 2 Tepper, Stewart J., Joshi, Shivang, Hirman, Joe, et al. Eptinezumab Treatment was Associated with Longer Interictal Periods and Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial. Available at Accessed June 4, 2025.3 Blumenfeld, Andrew, Patel, Foram, Kapur, Neha, et al. Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention. Available at Accessed June 4, 2025.4 Starling, Amaal, Regnier, Stephane, Soni-Brahmbhatt, Seema, et al. Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive anti-CGRP Treatment had Failed: Interim Results of an Ongoing Real-world Study. Available at Accessed June 4, 2025.5 Lipton, Richard B., IOR-02 - Patient perspectives of migraine symptomology: Insights from exit interviews from the anti-PACAP antibody phase 2 HOPE trial for migraine prevention. Available at Accessed June 4, 2025.6 Ailani, Jessica, Ashina, Messoud, Awad, Susanne F., et al. Long-term Improvements Following ≥50% Migraine Response to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analysis of the DELIVER Trial. Available at Accessed June 4, 2025.7 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at Accessed June 4, 2025.8 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at Accessed June 4, 2025.9 Jensen, Rigmor H., Lundqvist, Christofer, Schytz, Henrik W., et al. Eptinezumab and patient education in chronic migraine and medication-overuse headache: Results from the randomized, placebo-controlled RESOLUTION trial. Available at Accessed June 13, 202510 Yu, Shengyuan, Matsumori, Yasuhiko, Kim, Byung-Kun, et al. Efficacy and safety of eptinezumab in chronic migraine: A randomized placebo-controlled trial in a predominantly Asian population. Available at Accessed June 13, 2025.11 National Institute of Neurological Disorders and Stroke. Migraine. Available at: Accessed March 28, 2024.12 GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 [published correction] appears in Lancet. 2017;390(10100):1211-1259.13 American Headache Society. Headache. 2019; 59: 1–18.14 Buse DC, Fanning KM, Reed ML, et al. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019;59(8):1286-1299. doi: View source version on Contacts Brittany KorbDirector, Product Communications and Patient Advocacybrkr@
Business Wire
a day ago
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Lundbeck Advances Leadership in Migraine With New Data at the American Headache Society 67th Annual Scientific Meeting
DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck US, the US subsidiaries of H. Lundbeck A/S, today announced it will present one oral and eight poster presentations at the 67th Annual Scientific Meeting of the American Headache Society (AHS) in Minneapolis from June 19-22, 2025. The data presentations reinforce the need to look beyond monthly migraine days (MMDs) and the importance of a holistic approach to migraine care as suggested by data from eptinezumab-jjmr post-hoc analyses. VYEPTI ® (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below. 'Migraine disease affects over 40 million people in the U.S., 1 profoundly impacting every aspect of life for many,' said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. 'Lundbeck is energized to be at AHS, driving conversations on how we can better understand the holistic burden of migraine and redefine how we approach care. Our focus goes beyond just alleviating individual symptoms—we are committed to improving the overall quality of life for people living with migraine disease.' Analyses presented at AHS from several studies including clinical trials and real-world research continue to focus on novel ways to assess VYEPTI and study results and advance preventive migraine care: P-341: Eptinezumab Treatment was Associated with Longer Interictal Periods and Corresponding Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial: Individuals living with migraine who have longer periods of time between migraine attacks (interictal periods) may experience a reduced overall burden of migraine. A post-hoc analysis of the phase 3b DELIVER trial during weeks 1-12 (n=853) and weeks 1-24 (n=832) evaluated the association between the mean longest interictal period and improvements in patient-reported quality of life (QoL) outcomes. Results from this post-hoc analysis indicate the mean longest interictal period was larger with VYEPTI than as reported by patients receiving placebo during the first 24 weeks of the DELIVER trial. Among participants with >14- and >21-day mean longest interictal periods, a greater proportion of participants achieved clinically meaningful improvements in the 6-item Headache Impact test score (HIT-6; ≥5-point total score reduction) and Patient Global Impression of Change (PGIC; 'much improved' or 'very much improved' rating) with VYEPTI compared with placebo. 2 P-333: Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention: Researchers analyzed select phase 3 clinical trials to assess retention rates for adult participants who were treated with VYEPTI and other anti-CGRP mAbs for the prevention of migraine, including long-term eptinezumab trials: the 104-week, open label, single-arm PREVAIL trial and the 72-week DELIVER trial. In this retrospective cohort study of US claims data, VYEPTI showed high, long-term retention rates for preventive treatment in participants with chronic migraine and in those with migraine for whom 2-4 prior migraine preventive treatments have failed, suggesting a high level of participant satisfaction with continued treatment of VYEPTI. Similar results were observed in other anti-CGRP mAbs in this treatment group. 3 P-332: Baseline Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive Anti-CGRP Treatment Had Failed: Interim Results of an Ongoing Real-World Study: INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine initiating VYEPTI for the preventive treatment of migraine. In an interim analysis of the first 75 participants entering the INFUSE study, results indicate that individuals, despite having ≥1 prior a-CGRP preventive treatment, reported a long history of disease and high disease burden (with regard to frequency, severity and cognitive impairments). Interim results also showed that the level of concern about initiating an intravenous (IV) treatment was low and participants in the study generally had a positive infusion experience. 4 Further highlighting our commitment to pushing the boundaries on migraine care with preventive treatments, Lundbeck also will host a symposium titled, 'Why the interictal period matters: Striving for migraine freedom' with Dr. Amaal Starling and Dr. Stewart Tepper on Thursday, June 19 from 12:30 p.m. to 1:15 p.m. CT. 'For optimal migraine management, it's important to prioritize continuous improvement and a patient-centered approach,' said Dr. Amaal Starling, Neurologist, Mayo Clinic. 'These studies highlight the real-world impact of preventive migraine treatments that can provide sustained control, which may allow individuals to focus on their personal goals and live their lives to the fullest.' Additional migraine data being presented at AHS include: About VYEPTI ® VYEPTI ® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion. The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions. VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. INDICATION VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy. Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. Raynaud's Phenomenon: Development of Raynaud's phenomenon and recurrence or worsening of pre-existing Raynaud's phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. VYEPTI should be discontinued if signs or symptoms of Raynaud's phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud's phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. ADVERSE REACTIONS The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Full Prescribing Information and Patient Information or visit About Migraine Disease Migraine is a complex and disabling neurological disease that limits functionality and quality of life. 1 It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound. 1,11 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration. 12,13 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men. 1 It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study. The impact of migraine permeates into career, home life and relationships. 14 About INFUSE study INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine, initiating preventive treatment with eptinezumab-jjmr. Eligible participants were recruited by two infusion center networks and are being followed for 12 months after initiating eptinezumab-jjmr treatment. INFUSE includes adults ≥18 years of age with a diagnosis of migraine who tried ≥1 preventive a-CGRP treatment (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]). About DELIVER study DELIVER (NCT04418765) is a phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of eptinezumab-jjmr in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes (including: propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan) or botulinum toxin A/B (if documented that botulinum toxin was used for chronic migraine), and at least one failure being due to inadequate efficacy. Patients who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians´ confirmation specific to each treatment in the past 10 years. In the study, 892 patients were randomized to receive eptinezumab-jjmr 100 mg or 300 mg or placebo by IV infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of eptinezumab-jjmr vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, healthcare resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI). The safety and tolerability of eptinezumab-jjmr in the DELIVER study were similar to placebo and consistent with findings from previous eptinezumab-jjmr clinical trials. In DELIVER and earlier eptinezumab-jjmr studies, upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most commonly reported treatment-emergent adverse events (TEAEs). About PREVAIL study PREVAIL was a phase 3, open-label multi-site U.S.-based study that evaluated eptinezumab-jjmr 300 mg intravenous administration in 128 adults with chronic migraine (CM). PREVAIL included two treatment phases: the primary treatment phase included four infusions of eptinezumab-jjmr 12 weeks apart (Day 0, and Weeks 12, 24, and 36); the secondary treatment phase included up to four additional eptinezumab-jjmr infusions 12 weeks apart (Weeks 48, 60, 72, and 84). Further, patients were followed for 20 additional weeks after the final infusion until Week 104. The PREVAIL study evaluated the long-term safety of repeat doses of eptinezumab-jjmr 300 mg in patients with CM, as well as the pharmacokinetics, immunogenicity, and patient-reported outcomes (PROs). Patient-reported outcome measures included the Migraine Disability Assessment (MIDAS) questionnaire, patient-identified most bothersome symptom (PI-MBS) associated with migraine, Patient Global Impression of Change (PGIC), and 6-item Headache Impact Test (HIT-6). About a-PACAP a-PACAP monoclonal antibody is an investigational compound currently under development (phase 2) for the treatment of migraine. The compound is not commercially available globally. About Lundbeck Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) ('Lundbeck'), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit and connect with us on LinkedIn and X at @LundbeckUS. References 1 Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache, 64 (5), 516–532. 2 Tepper, Stewart J., Joshi, Shivang, Hirman, Joe, et al. Eptinezumab Treatment was Associated with Longer Interictal Periods and Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial. Available at Accessed June 4, 2025. 3 Blumenfeld, Andrew, Patel, Foram, Kapur, Neha, et al. Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention. Available at Accessed June 4, 2025. 4 Starling, Amaal, Regnier, Stephane, Soni-Brahmbhatt, Seema, et al. Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive anti-CGRP Treatment had Failed: Interim Results of an Ongoing Real-world Study. Available at Accessed June 4, 2025. 5 Lipton, Richard B., IOR-02 - Patient perspectives of migraine symptomology: Insights from exit interviews from the anti-PACAP antibody phase 2 HOPE trial for migraine prevention. Available at Accessed June 4, 2025. 6 Ailani, Jessica, Ashina, Messoud, Awad, Susanne F., et al. Long-term Improvements Following ≥50% Migraine Response to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analysis of the DELIVER Trial. Available at Accessed June 4, 2025. 7 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at Accessed June 4, 2025. 8 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at Accessed June 4, 2025. 9 Jensen, Rigmor H., Lundqvist, Christofer, Schytz, Henrik W., et al. Eptinezumab and patient education in chronic migraine and medication-overuse headache: Results from the randomized, placebo-controlled RESOLUTION trial. Available at Accessed June 13, 2025 10 Yu, Shengyuan, Matsumori, Yasuhiko, Kim, Byung-Kun, et al. Efficacy and safety of eptinezumab in chronic migraine: A randomized placebo-controlled trial in a predominantly Asian population. Available at Accessed June 13, 2025. 11 National Institute of Neurological Disorders and Stroke. Migraine. Available at: Accessed March 28, 2024. 12 GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 [published correction] appears in Lancet. 2017;390(10100):1211-1259. 13 American Headache Society. Headache. 2019; 59: 1–18. 14 Buse DC, Fanning KM, Reed ML, et al. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019;59(8):1286-1299. doi:
Calgary Herald
2 days ago
- Health
- Calgary Herald
Alberta to move to hospital-based leadership structure and eliminated AHS zones in latest health care restructuring
Alberta's refocusing of the health-care system continues with new plans to eliminate the 'bureaucratic vortex' which it says is hindering patient care. Article content In a video posted to X on Tuesday, Premier Danielle Smith announced the government's latest plans in the health-care reshuffling, which includes eliminating all five Alberta Health Services (AHS) zones and moving to a 'hospital-based leadership structure.' Article content Article content Article content 'This is what the current structure has created — distance from the problem and delays in the solution. It's costing us time. It's costing patients time, and it's costing Albertans the care they deserve,' Smith said. Article content Article content 'We're moving away from a heavy corporate administrative structure with more local decision making through hospital-based leadership.' Article content Under the new changes, hospitals will each have different leadership teams responsible for hiring, managing resources and troubleshooting. Smith said sites will be able to direct funding as they see fit to areas within the facilities with the most need. Article content The change would include eliminating all five AHS health zones and acute-care sites will be integrated into seven regional corridors which will have to report to Acute Care Alberta. According to a Tuesday press release, the sites will operate under the new leadership model and site operations will be managed by AHS through a hospital-based management framework. Article content Article content In a statement to Postmedia from the Ministry of Hospitals and Surgical Health Services, it said moving away from 'zone-based leadership' is expected to streamline decision-making and improve efficacy. Article content Article content 'AHS health zones are being replaced with health corridors to support an evidence-based approach to planning services, workforce, and infrastructure across Alberta's four new provincial health agencies,' the statement said. Article content 'These regional corridors reflect where Albertans access care and are informed by data on travel patterns, service utilization, and public feedback gathered during health-care refocusing engagement sessions. This new structure will help identify gaps in the health-care system and guide future investments in both operations and capital projects.' Article content The changes will be fully implemented by summer 2026, according to the province. The Ministry of Hospital and Surgical Health Services, AHS and Acute Care Alberta will be designing and establishing a new leadership and management model with an interim model to be established by November 2025.
CTV News
2 days ago
- Health
- CTV News
AHS warns of blue-green algae at Elk Island
Alberta Health Services (AHS) is warning visitors to Elk Island National Park of blue-green algae seen in the waters of Astotin Lake. The health authority said to avoid all contact with blue-green algae blooms and to wash with tap water as soon as possible if contact occurs. Do not swim or allow pets to swim or wade in areas where the algae is visible. Consider limiting human consumption of whole fish or fish trimmings from the lake. Do not feed any fish or fish trimmings to pets. Fish filets from the lake are safe for humans to eat. Blue-green algae, also known as cyanobacteria, can look like scum, grass clippings, fuzz or globs on the surface water. It can be blue-green, greenish-brown, brown and/or pinkish-red, and often smell musty or grassy. Blue-green algae Blue-green algae is seen near the shore in this undated photo. (Courtesy: Grand River Conservation Authority/ Skin irritation, rash, sore throat, sore red eyes, swollen lips, fever, nausea and vomiting and/or diarrhea can occur when exposed to blue-green algae or by consuming water containing the bacteria. Exposure to blue-green algae can cause death to pets. Waters of Astotin Lake that do not have visible blue-green algae can still be used for recreational purposes.
