FDA Accepts Supplemental New Drug Application of Rimegepant for Preventive Migraine Treatment
The Food and Drug Administration (FDA) has accepted and will review the recently submitted supplemental New Drug Application (sNDA) of rimegepant (Nurtec ODT; Biohaven Pharmaceuticals, New Haven, CN) for preventive migraine treatment. If granted approval, rimegepant would be the only calcitonin gene-related protein (CGRP)-inhibitor to be approved for both acute and preventive migraine treatment.
In the clinical trials for acute treatment, 21.2% of participants achieved freedom from pain for 2 hours compared with 10.9% treated with placebo (P<.001). In the clinical trials for preventive treatment, 347 participants who took rimegepant every other day had a 4.3 fewer migraine days per month compared with participants with placebo who had 3.5 fewer migraine days per month. Among those who took rimegepant every other day, 49.1% had at least a 50% reduction from baseline in the mean number of moderate-to-severe migraine days per month compared with 41.5% in the placebo group (P<.05).
Elyse Stock, MD, chief medical officer at Biohaven stated, "Unlike the injectable CGRP-targeting biologics, rimegepant offers the potential for a convenient oral medication with dual benefits for both the acute and preventive treatment of migraine, requires no injection, and has a half-life of approximately 11 hours that allows immediate cessation of therapy in the event of pregnancy, nursing, hypersensitivity reaction, or adverse reactions. Thus, rimegepant's safety and efficacy has the potential to address important unmet needs in the current landscape of preventive treatments of migraine."
The sNDA filing was based on the outcomes of Study 305 (NCT03732638) and Study 201 (NCT03266588) that supported the approval of rimegepant for the acute treatment of migraine. Study 305 determined statistically significant reduction from baseline in monthly migraine days in participants treated with rimegepant compared with placebo during the 3rd month of treatment. Rimegepant at 75 mg was launched in March 2020 for the acute treatment of migraine and is the first and only CGRP receptor antagonist available in an orally disintegrating tablet (ODT) designed for rapid onset of action. The most common adverse reaction in the trials for acute treatment was nausea (2%) in those who received rimegepant vs 0.4% of those who received placebo.