Research Summary

Safety, Tolerability of Once-Daily Rimegepant for Episodic Migraine Prevention in US Adults

Edited by:
Ashton L. Stahl

Key Highlights:

  • This was a real-world, open-label study of rimegepant 75 mg once daily over 24 weeks in adults with episodic migraine.
  • The majority of participants completed treatment with a favorable safety profile; no serious adverse events were reported.
  • The most common adverse events were nasopharyngitis, COVID-19, and nausea.
  • There were no clinically meaningful liver enzyme elevations or Hy’s law cases observed.

In adults with episodic migraine, once-daily oral rimegepant 75 mg showed a favorable safety and tolerability profile over 24 weeks, according to a recent study published in The Journal of Headache and Pain. This phase 4, 24-week, open-label safety study, conducted across 19 US sites, enrolled adults experiencing 4–14 migraine attacks per month to receive rimegepant 75 mg orally once daily. Concomitant standard-of-care acute migraine medications and stable preventive regimens were allowed. Investigators tracked on-treatment adverse events (AEs) occurring in ≥5% of participants, serious AEs, discontinuations due to AEs, and notable laboratory abnormalities. Efficacy was not evaluated in this study.

Study Findings
Overall, 250 participants received at least 1 dose of rimegepant, with 74.8% completing the 24-week treatment period. The average treatment duration was approximately 19.3 weeks. More than half (53.6%) experienced at least 1 on-treatment AE, most of which were mild. No serious AEs were reported, and only 2.8% of the participants discontinued the study due to AEs. The most common on-treatment events (≥5%) included nasopharyngitis (9.2%), COVID-19 (6.4%), and nausea (6.0%). Laboratory analyses showed occasional grade 3–4 abnormalities (eg, elevated LDL-C), but there were no significant elevations in liver transaminases or potential Hy’s law cases.

Clinical Implications
According to the study authors, the findings suggest that once-daily rimegepant 75 mg is well tolerated and has a favorable safety profile when used for up to 24 weeks in adults with episodic migraine, supporting its use for preventive therapy in real-world clinical settings.

Expert Commentary
“Overall, this study demonstrates that QD dosing of rimegepant 75 mg ODT for up to 24 weeks has a favorable safety profile and supports further evaluation of this dosing regimen for the prevention of episodic migraine,” the researchers concluded.

Reference
Antinew J, Fountaine RJ, Loprinzo V, et al. A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention. J Headache Pain. 2025 Dec 9. doi:10.1186/s10194-025-02225-7