The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intranasal zavegepant, an investigational calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults.
The NDA submission is supported by data from 2 double-blind, placebo-controlled studies (ClinicalTrials.gov Identifier: NCT04571060, NCT03872453) that evaluated the efficacy and safety of zavegepant in adults with at least a 1-year history of migraine (with or without aura) and migraine attacks lasting, on average, 4 to 72 hours if untreated. In both trials, patients were randomly assigned to receive a single intranasal dose of zavegepant or placebo.
Results from both studies showed that treatment with zavegepant was statistically superior to placebo on the coprimary endpoints of pain freedom and freedom from most bothersome symptom (nausea, photophobia, phonophobia) at 2 hours.
In the phase 3 trial, zavegepant was found to be superior to placebo across a total of 15 prespecified primary and secondary endpoints, including ultra-rapid onset endpoints (eg, 15 minute pain relief and return to normal function in 30 minutes) and multiple efficacy endpoints (eg, sustained pain freedom and sustained pain relief 2 to 24 hours and 2 to 48 hours post dose).
“If approved, zavegepant would provide a new treatment option for patients who need ultra-rapid relief, in as early as 15 minutes, and for those who experience nausea or vomiting and need a non-oral treatment option,” said Vlad Coric, MD, Chief Executive Officer and Chairman of Biohaven. “We have generated robust data from 2 intranasal zavegepant pivotal trials that were submitted with our NDA and look forward to bringing this new treatment option to people suffering from migraine.”
A Prescription Drug User Fee Act target date for the first quarter of 2023 has been set for the application.
US FDA accepts for review Biohaven’s New Drug Application (NDA) filing of intranasal zavegepant for the acute treatment of migraine. News release. Biohaven Pharmaceutical Holding Company Ltd. Accessed May 23, 2022. https://www.prnewswire.com/news-releases/us-fda-accepts-for-review-biohavens-new-drug-application-nda-filing-of-intranasal-zavegepant-for-the-acute-treatment-of-migraine-301552566.html