Biohaven Pharmaceutical Holding Company has announced that The Lancet has published the company’s positive results from a phase III clinical trial of rimegepant for the preventive treatment of migraine in adults. According to a press release by the company, these data show rimegepant was superior to placebo in the reduction of monthly migraine days.
Rimegepant was approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in February 2020. Rimegepant is marketed as NURTEC ODT.
According to Biohaven, rimegepant is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in an orally disintegrating tablet (ODT) designed for rapid onset of action.
Peter J. Goadsby, study co-author, professor of neurology at King’s College, London and the University of California, Los Angeles, commented, “These data demonstrate the continued innovation in migraine treatment aimed at CGRP mechanisms. This is the first time an oral CGRP migraine treatment has shown dual efficacy in both the acute and preventive treatment of migraine. With this flexibility, these therapies are truly disruptive and change the treatment paradigm for people living with migraine.”
Biohaven states that during the Phase III double-blind, randomised, placebo-controlled trial, 747 people with migraine were included. Rimegepant was superior to placebo on the primary endpoint of change in mean number of migraine days per month during weeks nine to 12. Rimegepant showed a −4.3 day reduction in monthly migraine days during the prespecified treatment period. Notably, the positive response to rimegepant was seen during the first four weeks of treatment and suggests an early onset of preventive effects.
Richard B. Lipton, study co-author, professor and vice-chair of neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center, New York, USA, stated, “Migraine is a prevalent and debilitating disease, affecting roughly one in six Americans, and many are not helped by current treatments. The results published in The Lancet demonstrate the significant clinical benefits of rimegepant for the preventive treatment of migraine. These data show the promise of a new approach to preventive treatment with an oral CGRP antagonist.”
Additionally, the press report claim rimegepant was also superior to placebo on multiple secondary endpoints. Notably, 49% of the rimegepant group had at least a 50% reduction from baseline in mean number of moderate to severe migraine days per month compared to 41% in the placebo group in weeks 9 through 12. Additionally, the incidence of adverse events was similar with rimegepant and placebo (36% vs 36%).
Vlad Coric, chief executive officer of Biohaven, New Haven, USA, commented, “Our strategic goal with the rimegepant development program is to offer patients a fast acting, quick-dissolve oral tablet with ‘dual-acting’ properties to treat migraine across the full spectrum from acute to preventive treatment. This publication in The Lancet demonstrates that rimegepant has the potential to prevent migraine in addition to its previously established efficacy in the acute treatment of migraine. People with migraine deserve a simple to use, single oral medication that can help them take back their days when a migraine strikes and also prevent future attacks.”
According to biohaven, this is the fourth pivotal randomised placebo-controlled clinical trial that demonstrated the efficacy and safety of rimegepant in migraine. Nurtec ODT (rimegepant) is currently approved by the FDA for the acute treatment of migraine in adults. The FDA accepted Biohaven’s supplemental New Drug Application (sNDA) for NURTEC ODT for the preventive treatment of migraine in October 2020 and the Prescription Drug User Fee Act (PDUFA) goal date is in 2Q2021.