
Innovative Drug Developer
Compiled by Draven
The 64th Annual Meeting of the American Headache Society in 2022 was held in Denver, Colorado, USA, from June 9-12. This article summarizes some of the research presented at the meeting.
The American Headache Society (AHS), founded in 1959, is a professional association dedicated to the research and treatment of headache and facial pain. Migraine is a common chronic neurovascular disease that can cause severe pain on one or both sides of the head, with associated symptoms including nausea, vomiting, and sensitivity to light, sound, or odors. If left untreated, a single episode can last from 4 to 72 hours and will recur, significantly impacting a patient’s work and life.
01Biohaven: Zavegepant Nasal Spray for the Treatment of Acute Migraine
Biohaven Pharmaceutical Submits 31 Abstracts, Including 3 Oral Presentations at the AHS Conference. The presentations showcased the complete Phase III data for zavegepant nasal spray as an acute treatment for migraine and provided data from a 52-week open-label extension study of Nurtec (ODT) (rimegepant), evaluating its use as a preventive treatment for migraine every other day and as a necessary acute treatment.
Nurtec Studies Show Drug is Safe and Effective, Helping Nearly Half of Patients Achieve 100% Reduction in Monthly Migraine Days. Zavegepant, a third-generation high-affinity, highly selective small molecule CGRP receptor antagonist developed by Biohaven, demonstrated statistical superiority in two primary endpoints (pain freedom at 2 hours and patients' most bothersome symptoms such as nausea, photophobia, or phonophobia) in a Phase II/III trial involving over 1,000 patients receiving the drug.
02Teva: Ajovy Injection for Preventive Treatment of Migraine
Teva Pharmaceuticals, the U.S. subsidiary of Teva Pharmaceutical Industries, presented eight abstracts at this conference, showcasing real-world data on the use of Ajovy (fremanezumab-vfrm) injection in diverse migraine patient populations. The presentations highlighted Ajovy's impact on patients with specific migraine treatment needs across various clinical settings and provided subgroup analysis data from the Phase IIIb FOCUS study, detailing the drug's use in patients with refractory migraine and comorbid obesity.
Data show that patients who received gepant treatment for one or more months before and after initiating AJOVY as add-on therapy, with three or more measurements of monthly migraine days (MMD), were included in the analysis: one at the pre-index date (gepant initiation), one at the index (AJOVY initiation), and one during the post-index period (gepant + AJOVY).
At the start of AJOVY, the average (standard deviation) for patients was 15.8 (7.4) MMD. The average time from the index date to the last visit was 9.4 (4.5) months. The average change in MMD from index to post-index date was -6.5 (1.0) days, representing a 41.1% reduction. Five patients (9.1%) experienced adverse events post-index; 3 injection site reactions, 1 uveitis, and 1 case of stomach discomfort.
03Satsuma: STS101 Nasal Powder for the Treatment of Acute Migraine
Satsuma Pharmaceuticals Submits Five Abstracts Highlighting STS101 (Dihydroergotamine (DHE) Nasal Powder) for Migraine, Providing Data Including Long-Term Safety and Tolerability from Phase III Trials, Subject Impression Data, Nasal Safety Data, and More. The drug is being developed for the acute treatment of migraine and features a unique proprietary nasal powder formulation administered via the company’s proprietary nasal delivery device.
04AbbVie: Migraine Portfolio Qulipta (atogepant), Ubrelvy (ubrogepant), BOTOX
AbbVie Submitted 29 Abstracts, Including 2 Oral Presentations and 1 Late-Breaker, Featuring Data from the Phase III PROGRESS Study of Atogepant for the Prevention of Chronic Migraine; These Data Will Support the Submission of a Supplemental New Drug Application (sNDA) to the FDA to Expand the Use of This Medicine. AbbVie Also Presented Clinical Data on Ubrelvy (ubrogepant) for the Acute Treatment of Migraine and BOTOX (onabotulinumtoxinA) for the Preventive Treatment of Chronic Migraine.
As the only pharmaceutical company offering three products, including preventive treatments for chronic and episodic migraines as well as acute treatment for migraines, AbbVie will continue to research three potential new indications for these drugs to help more patients.
Reference Source:
1、AbbVie, Biohaven, Teva and Satsuma Tackle Migraine at AHS
2、New Real-World Data Evaluating AJOVY® (fremanezumab-vfrm) Injection Use in Patients With Migraine Presented at 2022 American Headache Society Annual Meeting
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