Combined Clinical Trial Data Establish Safety and Efficacy of Nurtec ODT in Black or African American Adults for Acute Migraine Treatment

In a study presented at the 2023 Annual Scientific Meeting of the American Headache Society (AHS), pooled data from 3 clinical trials (NCT03235479, NCT03237845, NCT03461757) demonstrated that Black or African American adults treated with Nurtec ODT (rimegepant orally disintegrating tablet; Biohaven, New Haven, CT) 75 mg for the acute treatment of migraine achieved similar benefits to the overall trial population.

The study performed post hoc subgroup analysis from 3 double-blind, randomized, placebo-controlled, multicenter clinical trials of Nurtec ODT 75 mg for acute treatment in Black and African American adults with a ≥ 1 year history of migraine. Coprimary endpoints, defined as freedom from pain and freedom from the most bothersome symptom (MBS) at 2 hours postdose, were analyzed using Cochran-Mantel Haenszel tests and stratified by use of preventive medication. Of the total trial population (N = 3551; Nurtec ODT n = 1769, placebo n = 1782), 19.6% were Black or African American (n = 696; Nurtec ODT n = 365, placebo n = 331). Outcomes for the coprimary endpoints freedom from pain (Black or African American, 24.4% vs 18.2%, P=.0473; overall pooled, 20.1% vs 12.2%, P<.0001) and freedom from the most bothersome symptom (MBS) at 2 hours postdose (Black or African American, 43.1% vs 35.5% P =.0413; overall pooled, 36.4% vs 26.6%, P<.0001) demonstrated the overall efficacy of Nurtec ODT in both Black or African American populations and the overall pooled population. No serious adverse events were reported by treated participants.

This study was funded by Biohaven Pharmaceuticals and includes researchers from Michigan State University College of Human Medicine, Albert Einstein College of Medicine, Hattiesburg Clinic, University of Miami, Headache Center of Hope in Cincinnati, OH, Biohaven Pharmaceuticals, and Pfizer Inc.