It has previously been reported that intranasal vazegepant (Biohaven Pharmaceutical, New Haven, CT) 10 mg and 20 mg achieved statistical superiority to placebo on the coprimary regulatory endpoints of pain freedom and freedom from most bothersome symptoms at 2 hours in a phase 2/3 dose-finding trial. The end of the phase 2 clinical trial (NCT03872453) and nonclinical interaction with the Food and Drug Administration (FDA) for intranasal vazegepant was announced today. All issues raised for vazegepant by the FDA were addressed, allowing advancement of the 10 mg dose into a double-blind placebo-controlled phase 3 clinical trial.
Vlad Coric, MD, chief executive officer of Biohaven 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 midyear. If approved, this novel intranasal formulation of vazegepant will complement our recently approved, rimegepant (Nurtec ) 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." Dr. Coric added, "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."
Vazegepant is the newest member of a migraine platform to have demonstrated efficacy in a pivotal trial. On February 27, 2020, the FDA approved rimegepant orally disintegrating tablets 75 mg for the acute treatment of migraine in adults. Biohaven believes that intranasal vazegepant will be complementary to other calcitonin gene-related peptide-targeting agents, including rimegepant.
Robert Croop, MD, Biohaven's chief development officer stated, "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."
Duriel I. Hardy, MD, and Sona Narula, MD
Donna Stephenson, MD