Safety Profile
Greg P.
Actual Nurtec ODT patient.
*Per IQVIA as oral brand in class (oral CGRP receptor antagonists): number one prescribed and number one in new prescriptions, since 8/6/21. Data current as of 8/21/23.
Well tolerated for acute and preventive treatment1
MOST COMMON (≥2%) ADVERSE EVENTS
Percentage of patients that experienced nausea1,2
Percentage of patients
that experienced abdominal pain/dyspepsia1
In the pivotal trials, there were no serious treatment-related AEs reported by the rimegepant groups3,4,‡
<3%
discontinuation due to AEs
in 2 clinical trials4,5
The ODT and tablet formulations of rimegepant are bioequivalent.3
†A long-term open label safety study assessed the safety of rimegepant 75 mg with 1800 patients enrolled and 1798 patients evaluated for up to 52 weeks, including 1131 patients who were exposed to rimegepant 75 mg for at least 6 months, and 863 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month.1,5
‡A serious adverse event was defined as any event that meets any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a subject who received rimegepant, and others.6
The long-term safety profile of rimegepant 75 mg was studied in an open-label study that enrolled 1800 patients1,5
Enrollment Groups5
Stratified by history of moderate‑to‑severe migraine frequency and trial dosing regimen:
Rimegepant treatment5
Subjects were instructed to self-administer treatment as follows:
- The maximum dose in a 24-hour period is 75 mg. The safety of using more than 18 doses in a 30-day period has not been established.1
- Patients in the PRN dosing groups took an average of 7.7 doses per 4-week period, over the course of the 52-week study.5
- The ODT and tablet formulations of rimegepant are bioequivalent.3
EOD=every other day; PRN=as needed
*863 participants were exposed for at least one year.1
References: 1. Nurtec ODT. Package insert. Pfizer Inc. 2. Biohaven Pharmaceuticals Inc. BHV3000-303 Clinical Study Report. A phase 3, double‑blind, randomized, placebo‑controlled, safety and efficacy trial of BHV-3000 (rimegepant) orally disintegrating tablet (ODT) for the acute treatment of migraine. 3. Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019;394(10200):737-745. doi:10.1016/S0140-6736(19)31606-X 4. Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2020;397(10268): 51-60. doi:10.1016/S0140-6736(20)32544-7 5. Croop R, Berman G, Kudrow D, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine (study 201). Poster presented at: Virtual Annual Scientific Meeting of the American Headache Society; June 13, 2020. 6. Study BHV3000-303 Clinical Protocol. Clinical Trials.Gov. https://clinicaltrials.gov/ProvidedDocs/57/NCT03461757/Prot_000.pdf. Published July 23, 2018. Accessed January 13, 2023. 7. Data on File. RIM113. Pfizer Inc.