Long-Term Safety and Tolerability of Rimegepant for Patients With Migraine

In a recent multicenter, long-term, open-label trial, rimegepant, an orally administered calcitonin gene-related peptide receptor antagonist, was found to be safe and well-tolerated over the long term in individuals with migraine. The study demonstrated that rimegepant, whether used on an as-needed basis or with scheduled dosing, did not raise concerns about serious adverse events, drug-induced liver injury, or medication overuse headache.

Migraine is a common and debilitating condition that can impact patients’ quality of life. Despite available treatments, many individuals continue to experience inadequate relief or intolerable side effects. Consequently, there is a critical need for alternative treatments that are both effective and safe for long-term use. Rimegepant, a new treatment option, has shown promise for acute migraine attacks, but its long-term safety profile was not fully understood until this study.

The researchers enrolled 1800 adults aged 18 years and older, all with at least 1 year of migraine history. Participants were divided into three groups based on their frequency of migraine attacks and treatment regimen. Two groups (pro re nata [PRN] 2-8 and PRN 9-14) received one 75 mg rimegepant tablet as needed (up to once per day) for 52 weeks, depending on their attack frequency. A third group (every other day [EOD] + PRN) took one rimegepant tablet every other day for 12 weeks, in addition to as-needed doses on nonscheduled days.

The study found that the most common adverse events (AEs) were upper respiratory tract infection (8.8%), nasopharyngitis (6.8%), and sinusitis (5.1%). Most of these AEs were mild or moderate in severity and were not considered related to rimegepant. Serious AEs occurred in just 0.6% of participants, with only one case possibly related to the medication. There was no indication of drug-induced liver injury, medication overuse headache, or potential drug abuse during the study period.

“Rimegepant 75 mg up to once per day as EOD + PRN for 12 weeks or PRN for up to 52 weeks was safe and well tolerated,” the study authors concluded. “No signal of hepatotoxicity, potential drug abuse, or medication-overuse headache was identified.”

Reference

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):3331024241232944. doi:10.1177/03331024241232944