Affiliations: 1. Clinical Research Institute, Minneapolis, MN; 2. California Medical Clinic for Headache, Santa Monica, CA; 3. Biohaven Pharmaceuticals, New Haven, CT, USA; 4. University of Connecticut School of Pharmacy, Storrs, CT; 5. Albert Einstein College of Medicine, Bronx, NY USA
Objectives:
The objective of this study was to evaluate the long-term safety of rimegepant, an orally administered CGRP receptor antagonist FDA-approved for acute treatment of migraine. The objective of this analysis was to evaluate the safety and tolerability of oral rimegepant when taken for the acute treatment of migraine in adults concomitantly taking various injectable anti-CGRP monoclonal antibodies (mAbs) for preventive treatment.
Design and setting:
This was a multicenter, long-term, open-label safety study (Study 201, NCT03266588) in adults with 2-14 monthly migraine attacks of moderate to severe pain intensity. A subgroup experiencing 2-8 monthly moderate to severe attacks and taking a stable dose of an FDA-approved anti-CGRP mAb for preventive treatment took rimegepant 75 mg as needed up to once daily for acute treatment for 12 weeks.
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.
Results:
Of the 13 subjects enrolled and receiving erenumab (n=7), fremanezumab (n=4), or galcanezumab (n=2), 10 (77%) completed the study. Mean (SD) age was 49.9 (13.7) years, and 11 (85%) were female. Mean (SD) time on treatment was 9.6 (4.6) weeks; mean (SD) rimegepant exposure per 4 weeks was 7.8 (5.5) doses. Five (38%) subjects reported ≥1 adverse event (AE). Of these, 2 subjects had nasopharyngitis; no other AEs occurred in ≥2 subjects. Three subjects had AEs deemed unlikely or possibly related to treatment by the investigator: viral gastroenteritis (moderate severity), first degree atrioventricular block (mild), and dizziness (mild). No patients had serious AEs, AEs leading to discontinuation, or aminotransferase levels ≥3x the upper limit of normal.
Conclusions:
Rimegepant 75 mg, when used as an oral acute treatment for migraine in patients receiving injectable anti-CGRP mAbs for preventive treatment, demonstrated favorable tolerability and no safety issues. Studies involving larger patient populations are needed to confirm these findings.
Disclosures:
Gary Berman, MD, has received fees for speaker’s bureau from Amgen, Teva, Lilly, Allergan, Biohaven, and Alder. He has received research grants from Amgen, Teva, Lilly, Allergan, Biohaven, Axsome, Zosano, and Alder.
David Kudrow, MD, has received fees for advisory board from Alder, Biohaven, Eli Lilly, Amgen, and Xoc and for speaker’s bureau from Teva, Amgen, Novartis, and Eli Lilly. He has also received research support from Amgen, Novartis, Eli Lilly, Teva, Alder, Biohaven, Biogen, and Roche-Genentech.
Philip Halverson, MD, has received research support from Biohaven.
Meghan Lovegren, BS, is employed by and holds stock/stock options in Biohaven Pharmaceuticals.
Alexandra C. Thiry, 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.
Elyse G. Stock, MD, 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.
Robert Croop, MD, 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.
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 options in eNeura Therapeutics and Biohaven Pharmaceuticals.
Gary Berman, MD
Clinical Research Institute
825 Nicollet Mall Suite 1135
Minneapolis, MN 55402
Phone: 612-333-2200
Email: gdb@allergy-asthma-docs.com
David Kudrow, MD
California Medical Clinic for Headache
2001 Santa Monica Blvd.
Suite 880-W
Santa Monica, CA 90404
Phone: 310-315-1456
Email: dbkudrow@gmail.com
Philip Halverson, MD
Clinical Research Institute
825 Nicollet Mall Suite 1135
Minneapolis, MN 55402
Phone: 612-333-2200
Email: ph@allergy-asthma-docs.com
Meghan Lovegren, BS
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Tel: 203-404-0410
Email: meghan.lovegren@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
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
Yushan M. Zhang, PharmD
University of Connecticut School of Pharmacy
69 N Eagleville Rd
Storrs, CT 06269
Phone: 860-486-2129
Email: yushan.zhang@uconn.edu
Elyse G. Stock, MD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: elyse.stock@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
Robert Croop, MD
Biohaven Pharmaceuticals
215 Church Street
New Haven, CT 06510
Tel: 203-404-0410
Email: robert.croop@biohavenpharma.com
Vladimir Coric, MD
Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, CT 06510
Phone: 203-404-0410
Email: vlad.coric@biohavenpharma.com
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
