Nurtec-ODT(Rimegepant)

Nurtec-ODT (rimegepant) is an oral medication for the acute treatment of migraine. The proposed dose is 75 mg orally. In clinical trials, rimegepant demonstrated superior efficacy compared to placebo. At 2 hours post-dose, rimegepant resulted in 5% more patients achieving pain freedom and 8-12% more patients achieving freedom from their most bothersome symptom (MBS) compared to placebo. Specifically, 19.2% of rimegepant-treated patients achieved pain freedom at 2 hours, a 5% difference from placebo (p-value 0.0298). For absence of MBS at 2 hours, 36.6% of rimegepant-treated patients achieved this outcome, an 8.9% difference from placebo (p-value 0.0016). Photophobia freedom was achieved by 34.9% of rimegepant-treated patients, a 10.1% difference from placebo (p-value 0.001).

The safety profile of rimegepant was evaluated in a large patient population, with 5553 patients receiving at least one dose of rimegepant, and 3397 unique patients receiving at least one dose of 75 mg rimegepant. Common adverse events (occurring in >=1% of rimegepant-treated patients in double-blind placebo-controlled trials) included various infections, dyspepsia, and nausea. In open-label studies, common adverse events (occurring in >=2% of rimegepant-treated patients) included dyspepsia, nausea, abdominal pain, arthralgias, somnolence, dizziness, diarrhea, and headache. No deaths were reported during the clinical development program. The half-life of rimegepant is 11 hours.

The New Drug Application (NDA 212728) for rimegepant was submitted by Biohaven on June 27, 2019, and received Priority Status. The review was completed on February 26, 2020.