FDA OKs First Orally Disintegrating CGRP for Rapid Migraine Relief 

Megan Brooks

February 28, 2020

The US Food and Drug Administration (FDA) has approved rimegepant (Nurtec ODT, Biohaven), the first calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet for the acute treatment of migraine in adults.

In clinical testing, a single 75-mg dose of rimegepant provided rapid migraine pain relief with patients returning to normal activities within 1 hour, with sustained benefit lasting up to 2 days in many patients. The majority of patients (86%) treated with a single dose did not need a migraine rescue medication within 24 hours.

"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, London, UK, said in a news release from Biohaven.

"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," said Goadsby.

More than 3100 patients have been treated with rimegepant with more than 113,000 doses administered in clinical trials, including a 1-year long-term safety study, the company said.

In the phase 3 trial, rimegepant achieved statistical significance on the co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) 2 hours after administration compared with placebo.

Rimegepant also showed 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.

In many patients, the benefits of pain freedom, pain relief, return to normal function, and freedom from MBS with a single dose lasted up to 48 hours.

Rimegepant was generally well tolerated. The most common adverse reaction was nausea (2%) in patients who received rimegepant compared with 0.4% of patients who received placebo.

"Everyone knows someone living with migraine, yet it remains an invisible disease that is often overlooked and misunderstood," Mary Franklin, executive director of the National Headache Foundation, commented in the news release.

"The approval of Nurtec ODT is exciting for people with migraine as it provides a new treatment option to help people regain control of their attacks and their lives," said Franklin.

Nurtec ODT will be available in pharmacies in early March in packs of eight tablets. Each eight-tablet pack covers treatment of eight migraine attacks with one dose, as needed, up to once daily. Sample packs containing two tablets will also be made available to healthcare providers.

Rimegepant is not indicated for the preventive treatment of migraine. The company expects to report top-line results from its prevention of migraine trial later this quarter.

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