Biohaven Advances NOJECTION™ Migraine Platform With Completion Of Enrollment Of Pivotal Phase 2/3 Trial Of Vazegepant, The First Intranasally Administ…September 10, 2019
The Phase 2/3 trial is designed to measure efficacy on regulatory endpoints for acute treatment of migraine – pain freedom and freedom from the most bothersome migraine-associated symptom at 2 hours post-dose – for vazegepant across three doses (5 mg, 10 mg and 20 mg) versus placebo. The trial will also study other clinical measures considered critically important to people living with migraine, such as pain relief and the return to normal functioning.
Elyse Stock, M.D., CMO of Biohaven, commented, “Biohaven is proudly committed to innovating new treatment options for people living with the debilitating condition of migraine. Our Phase 2/3 trial of vazegepant represents the first late-stage study of an intranasally delivered CGRP receptor antagonist, propelling us a step closer to providing patients with multiple, easy-to-use formulations to treat migraine.” Dr. Stock added, “Vazegepant is complementary to our lead migraine asset, rimegepant, which has met the primary efficacy endpoints in three completed Phase 3 clinical trials and is currently under review with the FDA.”
Intranasal vazegepant utilizes the Aptar Pharma Unidose System (UDS), which is designed to enable systemic delivery of drugs without the need for injection or administration by a healthcare professional. This device is FDA-approved to deliver multiple drug products marketed in the U.S., and is used by thousands of people every day.
Robert Croop, M.D., Biohaven’s Chief Development Officer – Neurology, added, “We are excited to complete enrollment with vazegepant, our third-generation CGRP receptor antagonist, in this pivotal Phase 2/3 trial with the goal of ultimately providing patients with important new treatment options that can easily be self-administered whenever and wherever a migraine strikes.”
Vazegepant is the second of Biohaven’s CGRP receptor-targeting compounds to enter clinical trials. Biohaven’s multiple CGRP receptor antagonist product candidates, including rimegepant, and expanded array of formulations including intranasal delivery and Catalent’s Zydis® oral fast-dissolve tablet, are designed to meet patients’ needs across the spectrum from acute to preventive treatment of migraine.
Over 36 million Americans suffer from migraine. Migraine attacks can differ in intensity and frequency, with many being highly disabling. More than 90 percent of migraine sufferers are unable to work or function normally during an attack. In the Global Burden of Disease Study, updated in 2015, migraine was ranked as the seventh highest cause worldwide of years lost due to disability. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class specific to the acute treatment of migraine in over 25 years. This unique and specific mode of action potentially offers an alternative to current agents, particularly for patients…