Effects of Rimegepant 75 mg on Monthly Migraine Days: a 52-Week, Open-Label Extension Study

Abstract text (incl. figure legends and references)

ObjectiveAssess the effects of rimegepant 75 mg on monthly migraine days (MMDs) through 52 weeks of open-label treatment when dosed every other day (EOD) for preventive treatment plus as needed (PRN) for acute treatment on nonscheduled dosing days.MethodsOpen-label extension phase of a 12-week, randomized, double-blind, placebo-controlled study evaluating rimegepant 75 mg EOD for preventive treatment of migraine in adults aged ≥18 years with a history of 4-18 moderate-severe monthly migraine attacks. Subjects completing a 4-week observation period and 12 weeks of double-blind treatment could continue with open-label rimegepant 75 mg EOD for preventive treatment for 52 weeks. On nonscheduled dosing days, subjects could take rimegepant 75 mg up to once per day PRN for acute treatment.ResultsOf 741 subjects who received double-blind treatment, 603 (81.4% [rimegepant n=301, placebo n=302]) were treated in the open-label phase (mean age 42.6 years, 82.7% female, hx of 7.9 monthly mod-sev attacks). Mean (SD) number of rimegepant doses per month was 14.6 (2.45). The most common adverse events were upper respiratory tract infection (7.1%), nasopharyngitis (6.3%), and back pain (4.3%). Through 52 weeks of open-label rimegepant (Figure A), the frequency of MMDs consistently declined; mean (95% CI) changes from the observation period in MMDs were −5.1 (−5.49, −4.74) in Weeks 1-4 and −6.9 (−7.31, −6.56) in Weeks 49-52. The percentage of subjects with ≥50% reduction in moderate-severe MMDs from the observation period ranged from 63.6% (Weeks 1-4) to 80.9% (Weeks 49-52), ≥75% reductions ranged from 44.1% (Weeks 1-4) to 65.8% (Weeks 49-52), and 100% reductions ranged from 25.6% (Weeks 1-4) to 49.3% (Weeks 49-52; Figure B).ConclusionScheduled EOD preventive treatment with rimegepant 75 mg plus PRN acute treatment on nonscheduled days consistently reduced MMDs over 52 weeks. More than 80% of subjects had ≥50% reduction in moderate-severe MMDs; ~50% had a 100% reduction by Week 52.