Rimegepant (Nurtec ODT) became the approved by the FDA, manufacturer Biohaven announced on Thursday.
The oral calcitonin gene-related peptide (CGRP) receptor antagonist, , earned a new indication for migraine prevention in adults with less than 15 headache days per month, the company said.
The drug's to include the use of rimegepant 75 mg up to 18 doses/month, allowing for both acute and preventive treatment in the same patient.
Rimegepant is the first oral CGRP antagonist to earn the FDA's nod for migraine prevention. Its approval as preventive therapy, along with its acute treatment indication, "is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine," noted Peter Goadsby, MD, PhD, DSc, of the University of California, Los Angeles and King's College London, who received the 2021 Brain Prize for his groundbreaking work in CGRP, a neuropeptide thought to play a causal role in migraine pathophysiology.
"To have one medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine," Goadsby said in a statement.
The FDA decision was based on a double-blind, randomized, placebo-controlled with an open-label extension. The that the mean number of migraine days per month during weeks 9–12 was −4.3 days (95% CI –4.8 to –3.9) with rimegepant and −3.5 days (–4.0 to –3.0) with placebo (least squares mean difference −0.8 days, 95% CI −1.46 to −0.20; P=0.0099).
In the phase III study, 36% of 370 people who received rimegepant reported an adverse event, as did 36% of 371 people who received placebo. Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event.
Adverse events occurring in at least 2% of rimegepant-treated participants were nasopharyngitis, nausea, urinary tract infection, and upper respiratory tract infection. Nearly all adverse events were mild or moderate.
Rimegepant is approved for adults with episodic migraine only; its safety in children is unknown, Biohaven said. Patients who are allergic to rimegepant or its ingredients should not take the drug. Patients who have liver or kidney problems, who are pregnant or plan to become pregnant, or who are breastfeeding or plan to breastfeed should consult their physician.
Concomitant administration of rimegepant with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP should be avoided, as should another dose of rimegepant within 48 hours when administered with moderate inhibitors of CYP3A4.