Phase III clinical trial of Nurtec ODT meets co-primary endpoints in migraine.

Led by BioShin Limited, a subsidiary of Biohaven in China and South Korea, the randomized, regional, multi-centre study met the co-primary endpoints evaluating the efficacy and safety of the orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist. This is the fourth positive Phase III study of rimegepant for the acute treatment of migraine and the first to be conducted in Asia Pacific.

The study met its co-primary endpoints of freedom from pain (p<0.0001) and freedom from most bothersome migraine-associated symptom (mbs) including nausea, phonophobia or photophobia (p><0.0001) at 2-hours following a single oral dose of rimegepant. in the study, a single oral dose of rimegepant 75 mg provided significant relief of migraine symptoms and return to normal function at 2 hours and delivered sustained efficacy that lasted up to 48 hours for many patients.

Rimegepant showed a favourable safety and tolerability profile among study participants that was consistent with prior clinical trial results in the United States. Detailed data from the study will be presented at future medical meetings to help inform ongoing and future research.

Under the terms of the collaboration agreement between Biohaven and Pfizer, Pfizer has commercialization rights to rimegepant in markets outside of the U.S. Biohaven continues to lead research and development globally and retains the U.S. market. Rimegepant is commercialized as Nurtec ODT in the U.S. and is the only oral CGRP receptor antagonist approved for both the acute and preventive treatment of migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency with a decision expected in the first half of 2022.