Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: A randomized, phase 3, double-blind, placebo-controlled trial
The Lancet Sep 06, 2019
Croop R, Goadsby PJ, Stock DA, et al. - Through a phase 3, multicenter, double-blind, randomized, placebo-controlled trial involving 1,811 adults with previous history of migraine of ≥ 1 year enrolled to 69 US study centers, experts contrasted the efficiency, safety, and tolerability of a novel orally disintegrating tablet formulation of rimegepant 75 mg with placebo in the acute treatment of migraine. For freedom from pain and freedom from the most bothersome symptom, rimegepant orally disintegrating tablet was better than placebo at 2 hours post-dose. Nausea and urinary tract infection were the most prevalent adverse events. In each treatment group, one individual had a transaminase concentration of > 3 times the upper limit of normal, neither was associated with study medication, and no increases in bilirubin > 2 times the upper limit of normal were observed. Treated individuals did not disclose any serious adverse events. Therefore, a single 75-mg dose of rimegepant in an orally disintegrating tablet formulation was more efficient than placebo in the acute treatment of migraine. Moreover, tolerability was comparable to placebo, with no safety concerns.
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