Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japan
Yasuhiko Matsumori1, Koichi Ikeda2, Masako Kudo3, Tomofumi Ishikawa4, Yuko Hoshino4, Hiroki Yoshimatsu4, Alexandra Thiry5, Akio Arakawa4, Robert Croop6, Terence Fullerton5, Fumihiko Sakai7, Takao Takeshima8
1Sendai Headache and Neurology Clinic, Sendai-shi, Miyagi, Japan, 2Ikeda Neurosurgical Clinic, Kasuga-shi, Fukuoka, Japan, 3Department of Neurology and Gerontology, Iwate Medical University, Morioka-shi, Iwate, Japan, 4Pfizer R&D Japan, Shibuya-ku, Tokyo, Japan, 5Pfizer, Groton, CT, USA, 6Biohaven Pharmaceuticals, New Haven, CT, USA, 7Saitama International Headache Center, Saitama Neuropsychiatric Institute, Saitama-shi, Saitama, Japan, 8Headache Center, Department of Neurology, Tominaga Hospital, Osaka-shi, Osaka, Japan
Objective:
The primary objective was to compare the efficacy of rimegepant (RIM) 75 mg with placebo (PBO) for the acute treatment of migraine in participants living in Japan. A secondary objective was to compare the efficacy of RIM 25 mg with PBO to assess dose response.
Background:
This phase 2/3 trial (NCT05399459) was a double-blind, randomized, multicenter, evaluation of the efficacy and safety of RIM orally disintegrating tablet compared with PBO for the acute treatment of migraine in participants living in Japan.
Design/Methods:
Adults with a history of 2–8 migraine attacks/month of moderate or severe pain intensity treated a single migraine attack of moderate or severe pain intensity with RIM 25 mg, RIM 75 mg or PBO. The primary endpoint was participants (%) with pain freedom at 2 h postdose; secondary endpoints included pain relief, most bothersome symptom (MBS) freedom, return to normal function (all at 2 h postdose), and sustained pain relief and sustained pain freedom (each through 2–24 and 2–48 h postdose). Formal hypothesis testing was only conducted for RIM 75 mg vs PBO. Safety was assessed based on adverse events (AEs).
Results:
A total of 706 treated participants were evaluable for efficacy and safety. Response rates for the primary endpoint, pain freedom at 2 h postdose, were 21.0% (RIM 25 mg), 32.4% (RIM 75 mg) and 13.0% (PBO) (difference RIM 75 mg vs PBO = 19.4% [95% CI 12.0, 26.8], p<0.0001). Findings for secondary endpoints were consistent with the primary endpoint. On-treatment AEs were experienced by 7.1% (RIM 25 mg), 9.2% (RIM 75 mg) and 6.6% (PBO) of participants.
Conclusions:
RIM 75 mg demonstrated efficacy superior to PBO for the acute treatment of migraine, with a favorable safety profile, in participants in Japan. A dose-response relationship was observed for RIM. Funded by Pfizer.
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