Biohaven and Pfizer announce results of rimegepant trial for acute treatment of migraine

Biohaven Pharma and Pfizer yesterday announced positive top-line results from an Asia-Pacific, phase-III clinical trial of rimegepant in 1,431 adults for the acute treatment of migraine. Led by BioShin, a subsidiary of Biohaven in China and South Korea, the randomised, 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, Pfizer notified via a statement.

Further, according to the statement, this is the fourth positive phase-III study of rimegepant for the acute treatment of migraine and the first to be conducted in the Asia Pacific. The study met its co-primary endpoints of freedom from pain (p<0.0001) and freedom from the most bothersome Migraine‐Associated Symptom (MBS), including nausea, phonophobia or photophobia (p<0.0001) at two 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 two 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 US. Detailed data from the study will be presented at future medical meetings to help inform the ongoing and future research, the statement added.

Under the terms of the collaboration agreement between Biohaven and Pfizer, Pfizer has commercialisation rights to rimegepant in markets outside of the US. Biohaven continues to lead research and development globally, and retains the US market. Rimegepant is commercialised as Nurtec ODT in the US, 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 (EMA) with a decision expected in the first half of 2022. Rimegepant is approved for the acute treatment of migraine in Kuwait and the United Arab Emirates (UAE), and for the acute and preventive treatment of migraine in Israel, said the statement.