The Food and Drug Administration (FDA) has approved Nurtec™ ODT (rimegepant; Biohaven) for the acute treatment of migraine with or without aura in adults.
Nurtec ODT is a calcitonin gene-related peptide receptor antagonist administered via an orally disintegrating tablet. The approval was based on efficacy data from a randomized, double-blind, placebo-controlled phase 3 trial that compared Nurtec ODT with placebo in 1466 adult patients for the acute treatment of migraine with and without aura. Patients were randomized to receive Nurtec ODT 75mg once (n=732) or placebo (n=734). The primary end point was pain freedom and most bothersome symptom (MBS) freedom at 2 hours after dosing in patients who treated a migraine with moderate to severe pain.
Results demonstrated that a statistically significantly greater proportion of patients treated with Nurtec ODT achieved headache pain freedom (21.2% vs 10.9%; P <.001) and MBS freedom (35.1% vs 26.8%; P =.001) 2 hours after a single dose compared with placebo, respectively.
Moreover, Nurtec ODT was associated with statistically significant improvements in key secondary end points when compared with placebo. These included the percentage of patients with pain relief at 2 hours (59.3% vs 43.3%; P <.001), sustained pain freedom at 2-48 hours (13.5% vs 5.4%; P <.001), use of rescue medication within 24 hours (14.2% vs 29.2%; P <.001), and those reporting normal function at 2 hours after dosing (38.1% vs 25.8%; P <.001).
Additionally, the approval of Nurtec is supported by safety data from a long-term, open-label phase 2/3 trial involving 1798 patients. The most common adverse reaction reported was nausea (2% Nurtec vs 0.4% placebo). The safety of treating more than 15 migraines per 30-day period has not been established. The use of Nurtec should also be avoided in patients with severe hepatic impairment and end-stage renal disease.
Nurtec ODT will be supplied as 75mg orally disintegrating tablets in a blister pack of 8 and is expected to be available in early March 2020.
For more information visit nurtec.com.