FDA Approves Rimegepant for the Treatment of Migraine in Adults

Officials with the FDA have approved Biohaven Pharmaceutical’s rimegepant (Nurtec ODT) for the acute treatment of migraine in adults.

A quick-dissolving rimegepant tablet can provide fast pain relief, and return patients to normal function within 1 hour, according to Biohaven. The medication delivers sustained efficacy that lasts up to 48 hours for many patients. However, rimegepant is not indicated for the preventive treatment of migraine.

The medication works by blocking CGRP receptors, treating a root cause of migraine.

“Everyone knows someone living with migraine, yet it remains an invisible disease that is often overlooked and misunderstood. Almost all people with migraine need an acute treatment to stop a migraine attack as it occurs, which can happen without warning,” said Mary Franklin, Executive Director of the National Headache Foundation, in a press release.

The FDA approval of rimegepant is based on results from a pivotal phase 3 clinical trial (Study 303), and a long-term, open-label safety study (Study 201). In the phase 3 trial, rimegepant achieved statistical significance on the regulatory coprimary endpoints of pain freedom, and freedom from most bothersome symptom (MBS) at 2 hours post dose compared to placebo. The medication also demonstrated statistical superiority at 1 hour for pain relief, and return to normal function. The benefits of pain freedom, pain relief, return to normal function and freedom from MBS were sustained up to 48 hours for many patients. These benefits were seen with only a single dose of rimegepant.

The long-term safety study assessed the safety and tolerability of rimegepant with multiple doses used over up to 1 year. The study evaluated 1798 patients, who used rimegepant 75 mg as needed to treat migraine attacks, up to 1 dose per day. The study included 1131 patients who were exposed to rimegepant for at least 6 months, and 863 who were exposed for at least 1 year, all of whom treated an average of at least 2 migraine attacks per month.

The safety of treating more than 15 migraines in a 30-day period has not been established. The most common adverse reaction was nausea (2%) in patients who received the drug compared to 0.4% of patients who received placebo. In addition, hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with rimegepant.

Biohaven is a biopharmaceutical company that specializes in therapies for neurological diseases. Rimegepant is Biohaven's first product to be approved by the FDA, according to the company.

REFERENCE

Biohaven's NURTEC™ ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults [news release]. New Haven, CT; February 27, 2020: Biohaven Pharmaceuticals. https://www.prnewswire.com/news-releases/biohavens-nurtec-odt-rimegepant-receives-fda-approval-for-the-acute-treatment-of-migraine-in-adults-301013021.html Accessed February 28, 2020.