The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for rimegepant (Nurtec™ ODT; Biohaven) for the preventive treatment of migraine.

The sNDA is supported by data from a randomized, double-blind, placebo-controlled phase 2/3 study that assessed the efficacy and safety of rimegepant, a calcitonin gene-related peptide receptor antagonist, in adults who had migraines for at least 1 year and 4 to 18 moderate to severe migraine attacks per month over 3 months prior to enrollment. Patients were randomized to receive either rimegepant 75mg orally every other day (n=348) or placebo (n=347). The primary end point was the change from baseline in mean migraine days per month over the 12-week period.

Results showed that patients treated with rimegepant achieved a statistically significant reduction in monthly migraine days from baseline (-4.3 days vs -3.5 days with placebo; P <.05). Additionally, a reduction of 4.9 monthly migraine days was observed among patients treated with rimegepant not on concomitant preventive treatment (eg, topiramate and amitriptyline), compared with a 3.7 day reduction in the placebo group (nominal P =.002). 

Moreover, a greater proportion of rimegepant-treated patients reported a ≥50% reduction from baseline in the mean number of moderate to severe migraine days per month compared with placebo (49.1% vs 41.5%). 

The safety profile of rimegepant was consistent with that seen in previous studies. The most common treatment-emergent adverse reaction was nausea. The sNDA is also supported by a long-term, open-label safety study, which evaluated the safety and tolerability of rimegepant with multiple doses for up to 1 year. 

“Our goal with the Nurtec ODT development program has been to offer a fast acting, quick-dissolve oral tablet with ‘dual-acting’ properties, acute and preventive, to treat migraine across its full spectrum,” said Vlad Coric, MD, CEO of Biohaven. “We believe that the ease of use associated with a single oral medication will benefit people with migraine so that they can take back their days, and also provides the health care system with a cost-effective approach as opposed to paying for two separate drugs for acute and preventive treatment.”

A Prescription Drug User Fee Act (PDUFA) target action date for the application has been set for the second quarter of 2021.

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Nurtec ODT is currently approved for the acute treatment of migraine with or without aura. The product is available as 75mg orally disintegrating tablets in a blister pack of 8.

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U.S. FDA accepts Biohaven’s supplemental New Drug Application (sNDA) Of Nurtec™ ODT for the preventive treatment of migraine. [press release]. New Haven, CT: Biohaven Pharmaceutical; October 14, 2020.