Richard B. Lipton (Bronx, NY/ US), David Kudrow (Santa Monica, CA/ US), Timothy Smith (Saint Peters, MO/ US), Jessica Ailani (Washington, DC/ US), Lisa Kamen (Nerw Haven, CT/ US), Alexandra C. Thiry (Nerw Haven, CT/ US), Christopher M. Jensen (Nerw Haven, CT/ US), Vladimir Coric (Nerw Haven, CT/ US), Robert Croop (Nerw Haven, CT/ US)
Abstract text (incl. figure legends and references)
Objectives
Assess safety and tolerability of rimegepant 75 mg every other day (EOD) for the preventive treatment of migraine and as-needed (PRN) for acute treatment on nonscheduled dosing days.
Methods
This 1-year open-label extension phase of a 12-week, randomized, double-blind, placebo-controlled study (NCT03732638) of rimegepant for the preventive treatment of migraine included adults aged ≥18 years with a history of 4-18 moderate-severe monthly migraine attacks. Subjects completing 12 weeks of double-blind rimegepant 75 mg or placebo EOD could continue with rimegepant 75 mg EOD for 52 weeks. On nonscheduled dosing days, subjects could take rimegepant 75 mg up to once per day PRN. Safety assessments were adverse events (AEs) and clinical laboratory tests, including liver function tests. Subjects who took ≥1 dose of open-label rimegepant were analyzed. Months were 4-week intervals.
Results
Of 741 subjects who received double-blind treatment, 603 (81.4% [rimegepant n=301, placebo n=302]) were treated in the open-label extension (mean age 42.6 years, 82.7% female, hx of 7.9 monthly mod-sev attacks). The most common AEs (Figure) were upper respiratory tract infection (7.1%), nasopharyngitis (6.3%), and back pain (4.3%). The discontinuation rate due to AEs was 2.8%. Serious AEs (2.2%) were unrelated to rimegepant. Two deaths (0.3%), 1 due to aortic dissection related to Marfan syndrome and 1 due to sepsis, were also unrelated to rimegepant. Aminotransferases >3x the upper limit of normal (ULN) occurred in 3.4% of subjects; none had elevations in bilirubin >2x ULN. Mean (SD) number of rimegepant doses per month was 14.6 (2.45); 81.4% of subjects used ≤16 tablets per month.
Conclusion
One year of open-label rimegepant 75 mg EOD for preventive treatment of migraine plus PRN on nonscheduled dosing days for acute treatment up to once daily was safe and well tolerated with no liver safety concerns. Use of PRN treatment was limited, and >80% of subjects took ≤16 tablets per month.