Topline results were announced from a phase 3 study evaluating intranasal zavegepant, an investigational calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults.
The randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT04571060) 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. Patients were randomly assigned to receive a single dose of zavegepant 10mg intranasal spray (n=623) or placebo (n=646) as needed.
Results showed that treatment with zavegepant was statistically superior to placebo on the coprimary endpoints of pain freedom (24% vs 15%; P <.0001) and freedom from most bothersome symptom (40% vs 31%; P <.0012) at 2 hours. At 15 minutes post dose, pain relief was achieved by 16% of the zavegepant group vs 8% of the placebo group (P <.0015).
Patients treated with zavegepant demonstrated return to normal function as early as 30 minutes after dosing (P <.006). Zavegepant was also found to be superior to placebo on other secondary outcome measures including sustained pain freedom (2 to 24 hours and 2 to 48 hours post dose) and sustained pain relief (2 to 24 hours and 2 to 48 hours post dose) (all P <.05). The most common adverse event reported with zavegepant was abnormal taste.
“The trial results clearly show that the performance of this formulation exceeded expectations by demonstrating superiority over placebo on pain relief at 15 minutes and return to normal function by 30 minutes,” said Vlad Coric, MD, Chief Executive Officer at Biohaven. “The impressive efficacy, safety and tolerability profile shown in this trial highlights the potential of zavegepant to usher in a new era of non-oral CGRP targeting migraine therapies that may transcend the traditional boundaries of older legacy intranasal migraine approaches.”
The Company expects to file a New Drug Application for zavegepant with the Food and Drug Administration in the first quarter of 2022.
Biohaven reports positive topline results from pivotal migraine trial of intranasal zavegepant demonstrating ultra-rapid pain relief by 15 minutes; prepares for submission of New Drug Application. News release. Biohaven Pharmaceutical Holding Company Ltd. Accessed December 6, 2021. https://www.prnewswire.com/news-releases/biohaven-reports-positive-topline-results-from-pivotal-migraine-trial-of-intranasal-zavegepant-demonstrating-ultra-rapid-pain-relief-by-15-minutes-prepares-for-submission-of-new-drug-application-301437767.html.