Objective:

This study evaluated long-term safety and tolerability of once daily (QD) rimegepant 75 mg for episodic migraine (EM) prevention.

Background:

Rimegepant is well tolerated at approved doses; 75 mg as needed up to once per day for acute treatment of migraine and 75 mg every other day for prevention of EM. 

Design/Methods:

Adults with 4-14 migraine attacks per month received open-label oral rimegepant 75 mg QD for up to 24 weeks. Standard-of-care medications for acute treatment of migraine were permitted as needed. Endpoints included adverse events (AEs) occurring in ≥5% of participants, serious AEs, AEs leading to rimegepant discontinuation, and Grade 3–4 laboratory test abnormalities.

Results:

250 participants received ≥1 dose of rimegepant (female=82.4%, White=86.4%, mean age=42.6 years) and 74.8% completed open-label treatment. Mean (SD) time on rimegepant was 19.3 (8.7) weeks. Overall, 54.0% of participants had ≥1 AE, none had a serious AE, 1.6% had a severe AE, and 2.8% had an AE leading to rimegepant discontinuation. AEs occurring in ≥5% of participants included nasopharyngitis (9.2%), COVID-19 (6.4%), and nausea (6.0%). Grade 3–4 laboratory test abnormalities included low lymphocytes (0.4%), high creatine kinase (3.8%), low glucose (0.4%), high LDL cholesterol (LDL-C; 9.8%), high fasting LDL-C (9.3%) high non fasting LDL-C (10.2%), high potassium (1.3%), high triglycerides (0.9%), high fasting triglycerides (1.3%), and urine glucose (0.5%). No elevations in liver transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >5x the upper limit of normal (ULN) or potential Hy’s law cases (ALT or AST >3x the ULN concurrent with total bilirubin levels >2.0x the ULN) were observed.   

Conclusions: