A substudy was recently published in the Journal of Headaches show the results of the well tolerated rimegepant (Nurtec; Biohaven Pharmaceutical, New Haven, CT). In the substudy all 13 participants (11 women [85%]; mean age 49.9 years) were being treated with CGRP monoclonal antibodies (mAbs). A total of 224 doses were taken; the mean time in rimegepant treatment period was 9.6 (4.6) weeks. The mean 4‐week rimegepant exposure was 7.8 (5.5) doses. Five (38%) participants reported ≥1 on‐treatment adverse events. Two (15%) participants had mild or moderate nasopharyngitis. No other adverse events occurred in ≥2 participants. Three participants had adverse events of mild or moderate severity that were considered potentially treatment related. No participants had serious adverse events, adverse events leading to discontinuation, or aminotransferase levels >3× the upper limit of normal.
The substudy took place in a multicenter open‐label long‐term safety study in adults with 2 to 14 monthly migraines of moderate to severe pain. A subgroup experiencing 2 to 8 monthly attacks and taking a stable dose of a CGRP mAb also took rimegepant 75 mg up to once daily for acute treatment for 12 weeks.
Rimegepant was well tolerated as an oral acute treatment in individuals receiving CGRP mAbs as preventive treatment with no safety issues identified. The efficacy of CGRP mAbs for the preventive treatment of migraine and the small molecule CGRP receptor antagonist rimegepant for acute treatment has been demonstrated in randomized controlled clinical trials (NCT03732638).
The Food and Drug Administration (FDA) has approved 4 CGRP mAbs for preventive migraine treatment and 2 small molecule CGRP receptor antagonists for acute migraine treatment. Rimegepant may be safely used as acute treatment in participants also receiving a preventive regimen involving CGRP mAbs. There were 13 additional participants with migraine who simultaneously used rimegepant and either erenumab (n = 7), fremanezumab (n = 4), or galcanezumab (n = 2) and assess the rate of on‐treatment adverse events.
Jakai D. Nolan, DO, MPH, and Jacqueline A. Nicholas, MD, MPH
Michelle L. Dougherty, MD, FAES, FAAN
Bettina Balint, MD