A recently study of rimegepant, an investigational oral calcitonin gene–related peptide receptor (CGRP) blocker for migraine, resulted in a higher percentage of patients relieved of pain over placebo.
A recent study of rimegepant, an investigational oral calcitonin gene—related peptide receptor (CGRP) blocker for migraine, resulted in a higher percentage of patients relieved of pain over placebo. The results were published in the New England Journal of Medicine this month.
The study was led by researchers at Albert Einstein College of Medicine and Montefiore Health System.
In the multicenter, double-blind, phase 3 trial, adults with at least a 1-year history of migraine and 2 to 8 migraine attacks of moderate or severe intensity per month were randomized to receive rimegepant orally at a dose of 75 mg, or matching placebo, for the treatment of a single migraine attack.
Two hours after patients took the dose of rimegepant or placebo, they were assessed for 2 end points: pain relief, and freedom from their most bothersome symptom, other than pain. Participants chose their most bothersome symptom from a list, including intolerance to light, intolerance to loud sounds, or nausea.
The study included 1186 patients; 594 received rimegepant and 594 received placebo. Of those, 537 patients in the rimegepant group and 535 patients in the placebo group could be evaluated.
The overall mean age of the patients evaluated for efficacy was 40.6 years, and 88.7% were women.
In a modified intention-to-treat analysis, the percentage of patients who were pain-free 2 hours after receiving the dose was 19.6% in the rimegepant group and 12.0% in the placebo group (absolute difference, 7.6 percentage points; 95% confidence interval [CI], 3.3 to 11.9; P <.001).
The percentage of patients who were free from their most bothersome symptom 2 hours after the dose was 37.6% in the rimegepant group and 25.2% in the placebo group (absolute difference, 12.4 percentage points; 95% CI, 6.9 to 17.9; P <.001). The most common adverse events were nausea and urinary tract infection.
The study had a few limitations. There was no active comparator to rimegepant. Second, the assessment of the drug’s effect on a single attack did not permit assessment of the consistency of the drug on multiple effects over time in the same patient. Lastly, it is not known how the drug would perform in patients with cardiovascular disease.
All authors have a financial relationship with the drugmaker, which funded the study.
Lipton RB, Croop R, Stock EG, et al. Rimegepant, an oral calcitonin gene—related peptide receptor antagonist, for migraine. N Engl J Med. 2019; 381:142-149. doi: 10.1056/NEJMoa1811090.