Biohaven’s acute migraine treatment rimegepant showed numerically significant differences from placebo on pain relief, with benefit as early as 15 minutes postdose.
Jelena Pavlovic, MD, PhD
Results from 3 phase 3 clinical trials of rimegepant (Nurtec ODT; Biohaven) demonstrated that the acute migraine treatment was more effective than placebo on efficacy end points measured from 2 hours through 48 hours postdose.
Overall, sustained pain relief in that 48-hour window postdose was observed in 37.8% of patients (n = 1749; 95% CI, 35.5—40.0) who received rimegepant without rescue medication, compared with 24% of patients on placebo (n = 1758; 95% CI, 22.0–26.0). These data were accepted to the American Academy of Neurology (AAN) 2020 Annual Meeting.
Additionally, 22.3% (95% CI, 20.3—24.2) of patients in the rimegepant group sustained normal function from 2 to 48 hours postdose compared with 13.7% (95% CI 12.1–15.3) in the placebo groups. Pain relief at 2 hours following administration of rimegepant was observed in 57.9% (95% CI, 55.6–60.2) of patients compared to 43.9% (95% CI, 41.6–46.2) in the placebo groups.
Researchers noted that the agent numerically separated from placebo on pain relief as early as 15 minutes postdose and was significantly superior to placebo at 60 minutes for pain relief (36.8% vs 31.2%; P = .0314) and return to normal function (22.3% vs 15.8%; P = .0025).
Studies 301, 302, and 303, led by Jelena Pavlovic, MD, PhD, associate professor, department of neurology, Albert Einstein College of Medicine, were double-blind, randomized, placebo-controlled, multicenter trials of identical design that included a total of 3507 adults with migraine. Patients in Studies 301 and 302 were randomized to treat 1 migraine attack of moderate-to-severe pain intensity with 75 mg rimegepant or placebo while those in Study 303 were randomized to receive 75 mg of the orally disintegrating tablet (ODT) or placebo.
The therapy was approved by the FDA in February 2020 for the acute treatment of migraine in adults, with the agency’s decision based on results from Study 303 and the long-term, open-label safety trial, Study 201. In those studies, rimegepant achieved statistical significance on both co-primary end points of freedom from the most bothersome symptom (MBS) and pain freedom at 2 hours postdose compared to placebo.
The oral calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant became available for prescription in pharmacies across the US in March 2020. Shortly after, due to the COVID-19 pandemic, Biohaven and Cove, a company that focuses on specialized care and access for patients with migraine, formed a collaboration to distribute rimegepant through means of telemedicine.
In addition to the partnership, Biohaven announced it had enhanced its access to rimegepant by offering a 2-dose complimentary sample pack available with prescription, as well as a patient starter kit ad a copay card. Those who utilize Cove will have access to the copay card, and may lower monthly costs to as little as $0.
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Pavlovic J, Dodick D, Friedman D, et al. Rimegepant 75 mg provides early and sustained relief of migraine with a single dose: results from 3 phase 3 trials. Neurology. 2020;94 (15 Suppl). 2366.