Safety Profile
Ellie W.
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.
Generally well tolerated for acute and preventive treatment in clinical trials1
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 trials
4,5
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
‡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.5
The long-term safety profile of rimegepant 75 mg for the acute treatment of migraine was evaluated in an open label study that enrolled 1800 patients1,7
The long-term safety and tolerability of rimegepant were assessed in an open-label study of 1800 participants. Participants with a self-reported history of 2-8 (n=1033) or 9-14 (n=481) moderate-to-severe migraine attacks per month were treated as needed with rimegepant 75 mg oral tablet up to once per calendar day for 52 weeks. Participants with a self-reported history of 4-14 (n=286) moderate-to-severe migraine attacks per month took one rimegepant tablet every other day as scheduled dosing plus PRN dosing of one tablet on nonscheduled dosing days for migraine attacks of any intensity for 12 weeks.
PRN=as needed.
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. 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. 6. Croop R, Berman G, Kudrow D, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine (study 201) (4829). Neurology. 2020;94(suppl 15). 7. Croop R, Berman G, Kudrow D, et al. A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine. Cephalalgia. 2024;44(4):1-11.