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.
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.
For more information visit biohavenpharma.com.
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.