Rimegepant Dual Treatment Efficacy and Safety Maintained Over a Year of Treatment

In an open-label extension study (NCT03732638), adults (n-603) treatment with 75 mg of rimegepant (Nurtec; Biohaven, New Haven, CT) every other day, with the option of additional doses as acute treatment on the other days, had reduced monthly migraine days (MMD). Over a year of treatment moderate to severe MMD were reduced from a mean of approximately 1.8 MMD to 1.4 (standard deviation [SD] 1.7) MMD on scheduled dosing days and 1.4 (SD, 1.63) on nonscheduled dosing days.

Use of rimegepant for acute treatment on nondosing days was infrequent at 1.1 (SD, 1.53) times/month. Use of other allowed acute treatments occurred 0.2 (SD 0.59) times/month. At in-person visits at week 12 (n=357) and 52 (n=256), improvement on the Clinical Global Impression of Change-Clinician (CGI-C) was observed in 95.1% (95% CI, 92.9-96.7) and 98.3% (95% CI; 96.4-99.2), respectively.

Clinically and statistically significant decreases in migraine-related disability, as measured by greater than 5-point decreases on the Migraine Disability Assessment (MIDAS) questionnaire, were seen at weeks 12 (-22.9%; n=537) and 52 (-24.9%; n=398). Absenteeism and presenteeism were reduced, respectively by 12% and 11% at week 12 and 13% and 12% at week 52. 

Among participants who completed questionnaires about medication preferences and satisfaction at weeks 12 (n=357) and 52 (n=256), 83% preferred rimegepant to their prior medication and 12% rated it as preferable as their prior medication. Being very or completely satisfied with rimegepant was reported by 77%. Another 16% were somewhat satisfied with rimegepant. 

Participants in the open-label period had 4 to 18 moderate or severe headache days/month in the 3 months prior to the trial and experienced 7 to 17 attacks in an initial 4 week screening period. During the open-label extension, they received 30 rimegepant tablets/month and were instructed to take 1 tablet every other day and up to 2 tablets to treat an acute headache on nondosing days. 

Other allowed acute treatments on nondosing days were acetaminophen, aspirin, baclofen, metoclopramide, muscle relaxants, nonsteroidal anti-inflammatory drugs (NSAIDs), or promethazine. Use of preventive medication was also allowed if the dose had been stable for 3 months. 

Adverse events occurred in 14.8% of participants and were mostly mild, most commonly nasopharyngitis, upper respiratory tract infections, and back pain. Only 2.8% of participants discontinued treatment due to adverse events. No serious treatment-related adverse events occurred.