Biohaven Pharmaceutical has announced that it met with the FDA following completion of Phase 2 clinical trials of its intranasal vazegepant (BHV-3500) for the treatment of migraine and is ready to advance the 10 mg dose of the nasal spray into a Phase 3 trial. In December 2019, Biohaven reported topline data from a Phase 2/3 dose finding trial in which both 10 and 20 mg doses of intranasal vazegepant demonstrated statistical superiority to placebo.
Intranasal vazegepant, which Biohaven licensed from Bristol-Myers Squibb, is delivered via the Aptar Pharma Unit Dose System. Biohaven has said that vazegepant is suitable for a variety of additional delivery routes, including inhalation.
Biohaven Chief Development Officer, Neurology, Robert Croop said, “We are pleased to successfully complete our end of Phase 2 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.”
CEO Vlad Coric commented, “Based on this positive interaction with the FDA, we look forward to advancing our Phase 3 clinical trial of intranasal vazegepant 10 mg for the acute treatment of migraine mid-year. If approved, this novel intranasal formulation of vazegepant will complement our recently approved, Nurtec ODT (rimegepant) orally disintegrating tablet, currently marketed for acute treatment of migraine and could add another innovative treatment option to help those suffering with migraine obtain rapid relief. Biohaven has built a world-class field sales team that is fully equipped to deliver on our entire pipeline and if this planned Phase 3 trial is positive, we would have the potential of filing a New Drug Application (NDA) next year.”
Read the Biohaven Pharmaceuticals press release.
