The pharmaceutical company announced that rimegepant, for the acute treatment of migraines, demonstrated superiority to placebo and met the co-primary endpoints of pain freedom and freedom from the most bothersome symptom in 2 pivotal phase 3 trials.
Biohaven Pharmaceutical announced that its acute treatment for migraines achieved both co-primary regulatory endpoints in 2 pivotal phase 3 trials.
The pharmaceutical company’s rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraines, demonstrated superiority to placebo and met the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at 2 hours in both BVH3000-301 and BVH3000-302. Researchers noted that these results were demonstrated with 1 dose and without rescue medications. According to the release, the overall efficacy and safety results were consistent across both trials.
“Clinicians have long awaited novel treatment modalities for migraine. The results from these 2 studies are very exciting as rimegepant met its regulatory endpoints and also showed important clinical benefit to patients,” said Richard B. Lipton, MD, vice chair of neurology, professor of epidemiology and population health and director of the Montefiore Headache Center at the Albert Einstein College of Medicine, and chair of Biohaven’s CGRP scientific advisory board, in a statement.
In Study 301, pain freedom at 2 hours was 19.2%, compared to 14.2% in the placebo cohort. Similarly, pain freedom at 2 hours was 19.6% in Study 302, compared to 12% in the placebo cohort. The efficacy of the treatment over placebo at 2 hours or later ranged from 5% to 19% in Study 301 and ranged from 7% to 22% in Study 302.
Patients treated with rimegepant also experienced benefit in freedom from their most bothersome symptom—photophobia, phonophobia, or nausea. For the rimegepant cohorts in Study 301 and Study 302, freedom from the most bothersome symptom were 36.6% and 37.6%, respectively, compared to 27.7% and 25.2% for the placebo cohorts.
Onset of pain relief, defined by the researchers as transitioning from moderate-to-severe pain to either no pain or mild pain, was also observed early after treatment with rimegepant, with numerical separation evident between 30 to 45 minutes post-dosing. According to the researchers, by 2 hours after a single dose of the treatment, pain relief was achieved in over 55% of the participants.
“The topline data from our 2 pivotal trials show that a single, oral dose of rimegepant has the potential to be an effective and safe acute treatment for migraine, addressing both pain and most bothersome symptoms without the need for repeat dosing or rescue medicines,” said Vlad Coric, MD, chief executive officer, Biohaven, in a statement. “By combining positive efficacy results and a favorable safety profile with the ease of oral dosing, we believe the rimegepant will represent a significant improvement over existing treatment options.”
The researchers concluded that, following the results of the 2 trials, the efficacy and safety profile of rimegepant has now been consistently established across 3 randomized controlled trials to date. The pharmaceutical company plans on submitting a New Drug Application to the FDA for rimegepant in 2019.