Phase 3 Results for Rimegepant for Treatment of Migraine Being Presented
Data from 2 phase 3 pivotal trials of rimegepant (Biohaven, New Haven, CT) for treatment of patients with migraine will be presented at the 17th Biennial Migraine Trust International Symposium (MTIS) in London, UK September 9, 2018. Rimegepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist shown in phase 1 and 2 studies to be safe and effective for relieving the most bothersome symptoms in patients experiencing migraine.
In 2 completed phase 3 trials, Studies 301 and 302, 1,162 and 1,186 patients were randomized to receive a single dose of either rimegepant or placebo. Coprimary endpoints of pain freedom and freedom from patient’s most bothersome symptoms were achieved 2 hours after receiving a dose of rimegepant. Freedom from functional disability 2 hours posttreatment was also achieved for patients given rimegepant. The benefits were durable and significantly greater than that of patients treated with placebo. Patients who received rimegepant were also less likely to use rescue medication for migraine during the study. Rimegepant was generally well tolerated, with the most frequent adverse event, nausea, occurring in only 1.4% of rimegepant patients, as compared to 1.1% of patients on placebo across both studies. The overall safety of rimegepant was similar to placebo on tests of liver function.
"The data from these two pivotal Phase 3 trials show the potential of rimegepant as a much needed, new option for the acute treatment of migraine," said Richard B. Lipton, MD, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center, and Chair of Biohaven's CGRP Scientific Advisory Board.