Abstract Details

Title Oral Rimegepant Produces No Significant Effect on Blood Pressure When Administered Concomitantly with SC Sumatriptan

Topic Headache

Presentation(s) P3 - Poster Session 3 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-010

Objective Evaluate the effects of rimegepant on resting blood pressure (BP) when administered concomitantly with sumatriptan.

Background Sumatriptan has vasoconstrictive effects on cerebral and coronary arteries and has been shown to increase BP. Rimegepant is a small molecule CGRP receptor antagonist with demonstrated efficacy and safety in the acute treatment of migraine. People with migraine may combine medications to treat attacks, so the effects of rimegepant on BP when coadministered with sumatriptan were studied.

Design/Methods This was a single center, Phase 1, randomized, partially-blinded, placebo-controlled study in adult nonsmokers. On Days 1 and 5, subjects received 12 mg of sumatriptan as 2 SC 6 mg injections separated by 1 hour; Day 5 injections were administered 2 and 3 hours after oral rimegepant 75 mg or matching placebo. From Days 2 to 5, subjects received rimegepant or placebo once daily (randomized 6:1, rimegepant:placebo). Parameters for BP were the time-weighted average (TWA) of mean arterial pressure (MAP), diastolic BP (DBP), and systolic BP (SBP). Similar TWA of MAP was concluded if the upper bound of the 90% CI of the difference between rimegepant+sumatriptan on Day 5 and sumatriptan on Day 1 was <5 mmHg.

Results All 42 subjects who enrolled were treated and analyzed. There were no significant differences in the TWA of MAP, DBP, or SBP and no clinically meaningful PK interactions between rimegepant and sumatriptan. Overall, 39 (92.9%) subjects experienced ≥1 AE; all but 3 (related to sumatriptan) were mild. The most common AE was injection site reaction (59.5%). Two subjects experienced mild increases in heart rate and BP. No other clinically meaningful changes from baseline in laboratory values, vital signs, or ECGs were identified.

Conclusions No significant difference in BP was detected between rimegepant+sumatriptan vs sumatriptan alone. No clinically meaningful PK interactions were observed. Coadministration of rimegepant with sumatriptan was safe and well tolerated.

Authors/Disclosures
Michael Hanna, PhD (Mercury Medical Research & Writing) PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
Christopher Jensen, PharmD (Biohaven Pharmaceuticals)	Dr. Jensen has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Jensen has stock in Biohaven Pharmaceuticals.
Vladimir Coric	Vladimir Coric has received personal compensation for serving as an employee of Biohaven. Vladimir Coric has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Bioahven. Vladimir Coric has stock in Biohaven. Vladimir Coric has received intellectual property interests from a discovery or technology relating to health care.
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.

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