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Press Release

Emerging Migraine Therapies Show Promise in Basic and Clinical Highlights Presented at 18th Congress of the International Headache Society Sept. 7-10

International Headache Society
Posted on: 11 Sep 17

Research results presented by leaders in the field of headache medicine at the 18th Congress of the International Headache Society Sept. 7-10 reveal promising findings supporting the treatment of migraine and other headache disorders. The theme of the event is New Horizons, emphasizing the ongoing breakthroughs in headache medicine. Attracting nearly 1400 of the most elite neurologists and headache specialists from 69 countries around the world, the emerging therapies spotlit at the 4-day industry conference represent unprecedented advancement in migraine treatment and a necessary investment in the fight against a disabling disease that affects more than one billion people around the globe.

“This unprecedented event in headache medicine marks the turning point for a group of diseases that have endured a severe lack of understanding, damaging stigma, historic underfunding for research, and a painfully slow pace of treatment advances,” said Dr. David Dodick, President of the International Headache Society and Co-Chair of the Congress, in his welcoming remarks Sept. 7.

Here are some clinical highlights revealed at the congress.

Breakthroughs in Acute Treatment

  • Migraine Acute Therapy: Comparative Effects of Three Doses of Zomitriptan Patch (M207) and Placebo on Pain and Most Bothersome Symptom for the Acute Treatment of Migraine: The Zotrip Study: Results of a study showing the comparative efficacy of three doses of zomitriptan patch (M207) and placebo show that M207 (ZP-Zolmitriptan) 3.8 mg, the largest dose tested, was effective and well-tolerated for the acute treatment of migraine. (Abstract OC-MC-001)
  • In the SPARTAN study, Lasmiditan, a selective serotonin 1F agonist, demonstrated efficacy over placebo for the 50mg, 100mg, and 200mg doses. This confirms the efficacy of Lasmiditan for the acute treatment of migraine demonstrated in a previous large randomized placebo-controlled study – the SAMURAI study.
  • A Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of DFN-02 (Nasal Spray of Sumatriptan 10 mg + Permeation Enhancer) in Migraine With or Without Aura demonstrating superiority over placebo for the co-primary endpoints of freedom from pain and the most bothersome associated symptom at 2 hours.
  • Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine: A Randomised Controlled Trial: The PRospectivE Study of nVNS for the Acute Treatment of Migraine (PRESTO), a sham-controlled, double-blind, randomized study, evaluated the efficacy of non-invasive vagus nerve stimulation (nVNS; gammaCore®) for the acute treatment of migraine, with results that provide a clinical rationale for nVNS use in the acute treatment of episodic migraine. (Abstract OC-LB-002)
  • Cluster Headache and Other Trigeminal Autonomic Cephalalgias : Non-invasive Vagus Nerve Stimulation for the Acute Treatment of Episodic and Chronic Cluster Headache: Findings from the randomized, double-blind, sham-controlled ACT2 study of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache show that the device was superior to placebo in patients with episodic cluster headache, but not for patients with chronic cluster headache. (Abstract OC-MC-003)

Continued Breakthroughs in CGRP Research as it Relates to Treatment of Chronic and Episodic Migraine

  • Migraine Preventive Therapy : Efficacy of Erenumab in Subjects with Episodic Migraine with Prior Preventive Treatment Failure(s): The STRIVE trial was a large, multicenter, double-blind, placebo controlled, Phase 3 study of erenumab 70mg and 140mg, a fully human CGRP receptor monoclonal antibody. This study previously demonstrated both doses to be superior to placebo in reducing mean monthly migraine days. In a separate analysis of patients who had failed ≥ 1 or ≥ 2 previous oral preventive migraine medications, erenumab was shown to be superior to placebo in both subgroups. The odds of responding to erenumab increased in those who failed more than two prior preventive medications since the placebo response was attenuated. This analysis suggested that erenumab is effective in those patients who have failed multiple previous preventive medications. In a separate prospective trial in patients who had failed prior preventive medications, these results were confirmed. (Abstract OC-MC-002)
  • A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Eptinezumab in Frequent Episodic Migraine Prevention: Primary Results of the PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) Trial: PROMISE-1 is a Phase 3 study to evaluate the efficacy and safety of eptinezumab, an anti-CGRP monoclonal antibody, for the prevention of frequent episodic migraine (FEM). All three dosages studied, including 30mg, 100mg, and 300mg, achieved the primary endpoint and were superior to placebo with regard to the 50% responder rate. The 30mg and 300mg dose group achieved significantly higher 75% responder rates compared to placebo. In addition, the likelihood of experiencing migraine the day after the infusion was significantly lowered in the active versus placebo arms.
  • Efficacy and Safety of Two Dose Regimens of Subcutaneous Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine: Monthly and quarterly injections of Teva's CGRP-binding monoclonal antibody fremanezumab were found to produce a significant reduction in headache days for patients with chronic migraine. In a 16-week randomized, double-blind, placebo-controlled, parallel-group study in adults with chronic migraine, subjects receiving two doses of fremanezumab, or one dose of fremanezumab and two doses of placebo, reported significant reduction in headache days compared to chronic migraine patients receiving only placebo. Responder rates were superior in the fremanezumab treated patients and all secondary endpoints were achieved.
  • Efficacy and Safety of Two Dose Regimens of Subcutaneous Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Episodic Migraine: 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, tolerability and safety of monthly and quarterly subcutaneous dose regimens of fremanezumab, a fully humanized monoclonal antibody targeting CGRP, in the treatment of episodic migraine. Results demonstrated that patients treated with fremanezumab had a significant reduction in the number of monthly migraine days vs. placebo. Responder rates were superior in the fremenezumab treated patients and all secondary endpoints were achieved.
  • A Phase 3 Placebo-Controlled Study of Galcanezumab in Patients with Chronic Migraine: Results from the 3-month Double-blind Treatment Phase of the REGAIN Study: A Phase 3, placebo-controlled study of galcanezumab (GMB), a humanized monoclonal antibody that selectively binds to the CGRP, evaluated two doses, 120mg and 240mg and demonstrated that both doses were superior to placebo in overall reduction of monthly migraine headache days (MHD), with significantly higher percentages of patients with ≥50% reduction in monthly MHD. The 240 mg dose was also superior to placebo on key secondary endpoints. (Registered as NCT02614261 at ClinicalTrials.gov)
  • Phase 3 Studies (EVOLVE-1 & EVOLVE-2) of Galcanezumab in Patients with Episodic Migraine: Results from the 6-month Treatment Phase: Galcanezumab (GMB) is a monoclonal antibody targeting the CGRP ligand. GMB was investigated in two Phase 3 (EVOLVE-1 & EVOLVE-2) double-blind, six month studies in patients with episodic migraine, who received either 120 mg or 240 mg of GMB. Both doses were superior to placebo for the primary and all secondary endpoints. (Registered as NCT02614183 and NCT02614196 at ClinicalTrials.gov)
  • A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Erenumab on Exercise Time During a Treadmill Test in Patients with Stable Angina: Erenumab, a human anti-CGRP receptor monoclonal antibody, developed for preventive treatment of migraine, was administered intravenously at a dose of 140mg in patients with stable angina and established coronary artery disease. Compared to placebo, the change from baseline in total exercise time was non-inferior in the erenumab group, and there was no difference observed in the time to onset of ≥1 mm ST-segment depression, time to onset of exercise-induced angina and no difference in adverse events reported. The conclusion was that the inhibition of the CGRP receptor does not aggravate myocardial ischemia in an at-risk population of patients with stable angina.

For more research, developments and information from the 18th International Headache Congress, please visit the website at www.ihs-headache.com.

About the International Headache Society:

The International Headache Society is the world’s leading membership organization for all whose professional commitment, whatever their discipline, is to helping people whose lives are affected by headache. As a charity, the purpose of IHS is to advance headache science, education, and management, and promote headache awareness worldwide. Activities include publication of Cephalalgia, the biennial International Headache Congress, developing guidelines, the international headache classification, educating the next generation of headache specialists worldwide, online education materials and offering grants and fellowships to young physicians worldwide. For more information about the IHS, visit their website: http://www.ihs-headache.org/about-the-ihs

About Migraine/Headache:

Migraine is the third most prevalent and sixth most disabling medical illness in the world. Despite the more than 1 billion people affected by migraine around the globe, it is vastly underrecognized and undertreated, and there remains tremendous disparity in patient access to education, healthcare services, and drug, device, and non-pharmacological treatments. Individuals who experience migraine have symptoms that include nausea, sensitivity to light and/or odors, skin sensitivity, fatigue, mood change, dizziness, difficulty concentrating, neck pain and changes in vision, including seeing spots, stars, lines, flashing lights and zigzag lines. The risk of other serious diseases is significantly higher in those with migraine, including stroke, epilepsy, depression, anxiety and chronic pain. Despite this, only one of every three people talk with a doctor about their migraine attacks and of those, only half get the right diagnosis. There is also a massive shortage of specialists focusing on migraine, with one specialist for every 65,000 individuals living with migraine, which worsens the problem.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170911005891/en/

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Last updated on: 11/09/2017

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