Abstract Details

Title Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japan

Topic Headache

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-006

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.

Authors/Disclosures
Robert Fountaine PRESENTER	Robert Fountaine has received personal compensation for serving as an employee of Pfizer, Inc.. Robert Fountaine has or had stock in Pfizer, Inc.Robert Fountaine has or had stock in Viatris, Inc.
Yasuhiko Matsumori, Jr., MD, PhD	Dr. Matsumori has nothing to disclose.
Koichi Ikeda, MD	Mr. Ikeda has nothing to disclose.
Masako Kudo, MD	Dr. Kudo has nothing to disclose.
Tomofumi Ishikawa, PhD	Dr. Ishikawa has received personal compensation for serving as an employee of Pfizer. Dr. Ishikawa has stock in Pfizer.
Yuko Hoshino, PhD	Dr. Hoshino has received personal compensation for serving as an employee of Pfizer.
Hiroki Yoshimatsu, PhD	Dr. Yoshimatsu has received personal compensation for serving as an employee of Pfizer R&D Japan.
Alexandra Thiry, PhD	Dr. Thiry has received personal compensation for serving as an employee of Pfizer. Dr. Thiry has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Thiry has stock in Pfizer. Dr. Thiry has stock in Biohaven Pharmaceuticals.
Akio Arakawa, PhD	Dr. Arakawa has received personal compensation for serving as an employee of Pfizer. Dr. Arakawa has stock in Pfizer.
Robert Croop, MD	Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has received personal compensation for serving as an employee of Pfizer Inc.. Dr. Croop has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Collima LLC. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has stock in Actio Biosciences, Inc. . Dr. Croop has received research support from Pfizer Inc. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.
Terence Fullerton, PharmD (Pfizer Global Product Development)	Dr. Fullerton has received personal compensation for serving as an employee of Pfizer. Dr. Fullerton has stock in Pfizer.
Fumihiko Sakai, MD	Dr. Sakai has nothing to disclose.
TAKAO Takeshima	Dr. Takeshima has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sawai. Dr. Takeshima has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teijin. Dr. Takeshima has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hedgcock MedTech. Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Otsuka. Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Elli-Lilly Japan. The institution of Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Daiichi-Sankyo.

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