FDA OKs Fast-Acting Orally Disintegrating Tablet for Acute Migraine Treatment

Officials with the FDA have approved Biohaven’s fast-acting orally disintegrating tablet (ODT), rimegepant (Nurtec ODT), for the acute treatment of migraine in adults, according to a company announcement.

Rimegepant is the first calcitonin gene-related peptide (CGRP) receptor antagonist available in a ODT. In a single dose, rimegepant can provide fast relief and return patients to normal function within 1 hour, according to Biohaven. Rimegepant ODT is not indicated for the preventive treatment of migraine.

The approval of rimegepant ODT is based on results from the phase 3 clinical trial, Study 303, and long-term, open-label safety study, Study 201. A total of 1798 patients who used rimegepant 75 mg as needed to treat migraine attacks, up to 1 dose per day, were evaluated. Of these patients, 1131 were exposed to rimegepant for at least 6 months and 863 were exposed for at least 1 year, and all patients were treated an average of at least 2 migraine attacks per month. Rimegepant ODT was generally well tolerated in the phase 3 study, with the most common adverse reaction being nausea. The safety of treating more than 15 migraines in a 30-day period has not been established, according to Biohaven.

In the phase 3 study, 86% of patients treated with a single dose of rimegepant ODT did not use a rescue medication within 24 hours, and rimegepant ODT achieved statistical significance on the regulatory co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours post dose compared with placebo. Rimegepant ODT also demonstrated statistical superiority at 1 hour for pain relief (reduction of moderate or severe pain to no pain or mild pain) and return to normal function. For many patients, the benefits of pain freedom, pain relief, return to normal function, and freedom from MBS were sustained up to 48 hours, and this was seen with only a single dose.

“I see many patients in my practice whose lives are disrupted by migraine, afraid to go about everyday life in case of a migraine attack,” Peter Goadsby, MD, PhD, professor of neurology and director of the King’s Clinical Research Facility, King’s College Hospital, said in a statement. “Many feel unsure if their acute treatment will work and if they can manage the side effects. With the FDA approval of NURTEC ODT, there is renewed hope for people living with migraine that they can get back to living their lives without fear of the next attack.”

Rimegepant ODT will be available in pharmacies in early March 2020 in packs of 8 tablets, Biohaven said.

References:

1. Biohaven’s Nurtec ODT (Rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults [news release]. Biohaven’s website. https://www.biohavenpharma.com/investors/news-events/press-releases/02-27-2020. Accessed February 28, 2020.