The company said the decision to advance the CGRP receptor antagonist into late-stage studies followed a successful end-of-phase meeting with the U.S. Food and Drug Administration.
Connecticut-based Biohaven Pharma is advancing intranasal vazegepant into Phase III trials for the treatment of acute migraine.
The company said the decision to advance the CGRP receptor antagonist into late-stage studies followed a successful end-of-phase meeting with the U.S. Food and Drug Administration. Biohaven said it plans to advance the 10 mg dose of intranasal vazegepant into Phase III after addressing concerns raised by the regulatory agency. In a Phase II/III trial, Biohaven reported that the 10 and 20 mg doses of Vazegepant proved to be statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms of photophobia, phonophobia and nausea at two hours following a single dose.
“We are pleased to successfully complete our end-of-phase II meeting with the FDA so that we can continue to advance the development of intranasal vazegepant. In the prior clinical trial, intranasal vazegepant showed evidence of rapid onset with pain relief as early as 15 minutes, return to normal function at 30 minutes and sustained benefits through 48 hours. Patients with migraine deserve multiple therapeutic options to better treat their migraines and return to their daily lives,” Robert Croop, Biohaven’s chief development officer in Neurology said in a statement.
Vlad Coric, chief executive officer of Biohaven, said the company plans to begin the Phase III trial in the middle of the year. If the trial is successful and vazegepant is approved, Coric said it will complement the recently-approved Nurtec ODT (rimegepant). Nurtec ODT was approved in February for the acute treatment of migraine in adults. Nurtec ODT, also a CGRP-inhibitor, disperses almost instantly in a person’s mouth without the need for water. If vazegepant continues to show efficacy throughout the Phase III trial, Coric said the company could file a New Drug Application next year. With the approval of Nurtec ODT, Coric noted that the company already has a “world-class field sales team” that is equipped to deliver the company’s products.
Migraine is one of the most common neurological disorders characterized by episodic headache, as well as other associated manifestations, such as nausea, vomiting, phonophobia, which is a fear of loud noises, and/or photophobia, light sensitivity. It is estimated that 12% to 14% of all people, more than a billion worldwide, are affected by migraine headache. There is a significant unmet need for new acute treatments as more than 90 percent of migraine sufferers are unable to work or function normally during an attack.
The two Biohaven drugs are in a new class of drugs called gepants. Gepants’ method of action targets the receptors for the CGRP protein, which is associated with migraine. Gepants ease the pain and other symptoms by blocking the CGRP pathway. Calcitonin gene-related peptide (CGRP) is a popular target for the treatment of migraine and chronic headaches and multiple companies have focused their attention on developing these kinds of treatments.
