PHILADELPHIA — A single dose of oral rimegepant, a small molecule antagonist to the calcitonin gene-related peptide, may provide safe, fast, and sustained relief from migraine, according to results from a phase 3 trial presented at the 61st Annual Scientific Meeting of the American Headache Society, held July 11 to 14 in Philadelphia, Pennsylvania.
In this double-blind multicenter phase 3 trial (Clinicaltrials.gov identifier: NCT03461757), adults (age ≥18 years; mean age, 40 years; 85% women) with a ≥1-year history of migraine were recruited and randomly assigned to treatment of moderate to severe migraines with an orally dissolving tablet (ODT) of 75 mg rimegepant (n=669) or placebo (n=682). Coprimary endpoints were 2-hour pain freedom as well as freedom from the most bothersome symptom. The researchers also examined safety (including adverse events [AEs]), electrocardiogram results, vital signs, and routine laboratory test results.
A greater percentage of patients treated with rimegepant vs placebo reported pain freedom at 2 hours postdose (21.2% vs 10.9%, respectively; P <.0001) as well as freedom from the most bothersome symptoms (35.1% vs 26.8%, respectively; P =.0009). Rimegepant was also superior to placebo for pain relief (P =.0314) and freedom from functional disability (P =.0025) 1 hour postdose, and for pain freedom (P <.0001) and freedom from the most bothersome symptom (P =.0128) at 90 minutes postdose. In the absence of rescue medication, rimegepant was also superior to placebo for sustained pain freedom (P <.0001), sustained pain relief (P <.0001), sustained freedom from the most bothersome symptom (P =.0018), and sustained freedom from functional disability (P <.0001) for 48 hours after a single dose. Rimegepant was found to be superior to placebo on 21 end points. A total of 85.8% of participants did not resort to rescue medication in the 24 hours following rimegepant treatment.
Safety and tolerability outcomes were comparable between the rimegepant ODT and placebo groups. The most frequently reported on-study AEs were nausea (rimegepant, 1.6%; placebo, 0.4%) and urinary tract infection (rimegepant, 1.5%; placebo, 0.6%). No on-study serious AEs were reported.
“These results of the first phase 3 clinical trial with rimegepant ODT demonstrate the potential early therapeutic action and clinical utility of rimegepant ODT for the acute treatment of migraine,” noted the researchers.
Lipton R, Coric V, Stock E, et al. Efficacy, safety, and tolerability of rimegepant 75 mg orally dissolving tablet for the acute treatment of migraine: results from a phase 3, double-blind, randomized, placebo-controlled trial, study. Presented at: 61st Annual Scientific Meeting of the American Headache Society, July 11-14, 2019, Philadelphia, PA. Abstract 634398.