Abstract Details

Title Patient Preference and Improved Clinical Global Impression of Change with Rimegepant for the Acute Treatment of Migraine: Results from a Long-Term Open-Label Safety Study (Study 201)

Topic Headache

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-007

Objective Assess preference of medication compared to previous treatments and clinical global impression of change (CGI-C) versus baseline in subjects using rimegepant, an orally administered small molecule CGRP receptor antagonist, in a long-term safety study for the acute treatment of migraine.

Background Preference of medication and CGI-C are clinically meaningful patient reported outcomes in trails of acute treatments for migraine. These measures have not yet been evaluated in subjects using rimegepant.

Design/Methods This was a multicenter, long-term, open-label safety study (Study 201) in adults with a history of 2-14 monthly migraine attacks of moderate to severe pain intensity. Subjects used rimegepant 75 mg orally as needed up to once daily to treat attacks of any pain intensity for 52 weeks. An exploratory objective was to assess preference of rimegepant compared to previous treatments and CGI-C relative to baseline. Improvement on CGI-C was defined by a response of very much improved, much improved, or minimally improved. Preference of medication was recorded by participants via an eDiary and CGI-C was clinician administered. Percentages are based on the number of subjects with non-missing data at the respective visit.

Results Altogether, 1514 subjects began the 52-week treatment period. Rates (95% CI) of subjects who preferred rimegepant over their previous acute treatments at week 24 (n=1027) and week 52 (n=882), were 79% (76, 81) and 80% (77, 82), respectively. Rates (95% CI) of subjects who were considered improved from baseline on the CGI-C scale at week 24 (n=1213) and week 52 (n=979), were 89% (87, 90) and 91% (89, 93), respectively.

Conclusions Over 52 weeks of acute treatment, 4 in 5 subjects preferred rimegepant to their previous migraine medications while 9 in 10 experienced clinical improvement versus baseline.

Authors/Disclosures
Christopher Jensen, PharmD (Biohaven Pharmaceuticals) PRESENTER	Dr. Jensen has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Jensen has stock in Biohaven Pharmaceuticals.
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.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine)	Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
Elyse Stock	Elyse Stock has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Flagship Pioneering Management. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol-Myers Squibb. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Optinose. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abpro. An immediate family member of Elyse Stock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Adagio. Elyse Stock has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Biohaven Pharmaceuticals. Elyse Stock has received stock or an ownership interest from Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received stock or an ownership interest from BIohaven Pharmaceuticals.
	No disclosure on file
Charlie Conway	Charlie Conway has received personal compensation for serving as an employee of Biohaven Pharmaceuticals Inc. Charlie Conway has received stock or an ownership interest from Biohaven Pharmaceuticals.
	No disclosure on file
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.
Gilbert J. L'Italien	Gilbert J. L'Italien has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Gilbert J. L'Italien has stock in biohaven pharmaceuticals.