Patient Preference And Improved Clinical Global Impression Of Change With Rimegepant 75 Mg For The Acute Treatment Of Migraine: Results From A Long-Term Open-Label Safety Study (Study 201)

Authors: Ira Turner, MD,1 Jelena M. Pavlovic, MD, PhD,2 Richard B. Lipton, MD,2 Robert Croop, MD,3 Elyse G. Stock, MD,3 Alexandra Thiry, PhD,3 Charles M. Conway, PhD,3 Meghan Lovegren, BS,3 Vladimir Coric, MD,3 Gilbert L’Italien, PhD,3 Christopher M. Jensen, PharmD3

Affiliations: 1. Island Neurological Associates, Plainview, NY; 2. Albert Einstein College of Medicine, Bronx, NY, USA; 3. Biohaven Pharmaceuticals, New Haven, CT, USA

Objectives:
The objective of this analysis was to assess preference of rimegepant compared with previous acute treatments and clinical global impression of change (CGI-C) versus baseline in subjects using oral rimegepant up to once daily for the acute treatment of migraine.

Design and setting:
This multicenter, long-term, open-label safety study was conducted 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 up to 52 weeks. An exploratory objective was to assess preference of rimegepant compared with previous acute treatments for migraine and CGI-C relative to baseline. Preference of medication was recorded by subjects in an electronic diary, and the CGI-C was administered by clinicians. Percentages are based on the number of subjects with nonmissing data at the respective visit.

Patients:
Adults 318 years of age with 31-year history of migraine.

Main outcome measures:
The primary outcome was to assess the safety and tolerability of rimegepant. Preference of medication and CGI-C were exploratory outcome measures.

Results:
Altogether, 1514 subjects began the 52-week treatment period. The percentages (95% CIs) 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. Of note, the most common medications used within 14 days of trial enrollment included ibuprofen; fixed combination acetaminophen, aspirin, and caffeine; and sumatriptan. The percentages (95% CIs) of subjects who were considered improved versus 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 with rimegepant 75 mg, 4 in 5 subjects preferred rimegepant to their previous migraine medications, and 9 in 10 subjects experienced clinical improvement relative to baseline.

Disclosures:

Ira Turner, MD, has received research support or served as a consultant or member of the advisory board or speakers’ bureau for Alder, Allergan, Amgen, ATI, Biohaven, Depomed, ElectroCore, Impax, Lilly, Novartis, Promius, Revance, Supernus, Teva, and Theranica.

Jelena M. Pavlovic, MD, PhD is a consultant for Allergan and serves on the advisory board for Biohaven.

Richard B. Lipton, MD, serves on the editorial board of Neurology and Cephalalgia and as senior advisor to Headache but is not paid for his roles on Neurology or Headache. He has received research support from the NIH. He also receives support from the Migraine Research Foundation and the National Headache Foundation. He receives research grants from Allergan, Amgen, Dr. Reddy’s Laboratories, and Novartis. He has reviewed for the NIA and NINDS and serves as consultant, advisory board member, or has received honoraria from Alder, Allergan, Amgen, Autonomic Technologies, Avanir, Biohaven, Boston Scientific, CoLucid, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Teva, and Vedanta. He receives royalties from Wolff’s Headache (8th Edition, Oxford Press University, 2009) and Informa. He holds stock and options in Biohaven Pharmaceuticals.

Robert Croop, MD, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Elyse G. Stock, MD, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Alexandra Thiry, PhD, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Charles M. Conway, PhD, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Meghan Lovegren, BS, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Vladimir Coric, MD, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Gilbert L’Italien, PhD, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Christopher M. Jensen, PharmD, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.

Ira Turner, MD
Island Neurological Associates
824 Old Country Rd #1
Plainview, NY 11803
Tel: (516) 822-2230
Email: bake29@aol.com

Jelena M. Pavlovic, MD, PhD
Albert Einstein College of Medicine
1225 Morris Park Avenue
Van Etten, Room 3C9B
Bronx, NY 10461
Phone: 718.430.8363
Email: jpavlovi@montefiore.org

Richard B. Lipton, MD
Montefiore Medical Center
The Saul R. Korey Department of Neurology
Albert Einstein College of Medicine
1165 Morris Park Avenue, Rousso Building, Room 332
Bronx, NY 10461
Phone: 718-430-3886
E-mail: Richard.Lipton@einstein.yu.edu

Robert Croop, MD
Biohaven Pharmaceuticals
215 Church Street
New Haven, CT 06510
Tel: 203-404-0410
Email: robert.croop@biohavenpharma.com

Elyse G. Stock, MD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: elyse.stock@biohavenpharma.com

Alexandra C. Thiry, PhD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: alexandra.thiry@biohavenpharma.com

Charles M. Conway, PhD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: charlie.conway@biohavenpharma.com

Meghan Lovegren, BS
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Tel: 203-404-0410
Email: meghan.lovegren@biohavenpharma.com

Vladimir Coric, MD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: vlad.coric@biohavenpharma.com

Gilbert L’Italien, PhD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: gilbert.litalien@biohavenpharma.com

Corresponding author:

Christopher M. Jensen, PharmD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: christopher.jensen@biohavenpharma.com

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