Calcitonin gene-related peptide(University of Sherbrooke)

To assess tablet utilization patterns and describe pre-treatment characteristics among new users of rimegepant.

Rimegepant is the only oral calcitonin gene-related peptide antagonist approved in the United States for both the acute and preventive treatment of migraine.

We conducted a retrospective cohort study of people with migraine who initiated treatment with rimegepant using two US commercial claims databases (MarketScan and Optum). Patients (≥18 years old) with migraine who newly initiated rimegepant were included. Patients were stratified into two groups representing acute (quantity = 8) and prevention (quantity = 15 or 16) use cohorts. Baseline characteristics and medication use history were assessed on index and during the 365-day pre-index period. Rimegepant utilization periods were calculated based on days supplied and varying approaches to define use periods. Tablet quantity per 30 days was reported separately for both acute and prevention cohorts.

In MarketScan, a total of 14,037 rimegepant users were identified; 11,195 (79.8%) in the acute group and 1,880 (13.4%) in the prevention group. Rimegepant utilization for acute use was 4.9 ± 2.1 tablets per 30 days and for preventive use was 13.1 ± 7.7 tablets per 30 days. There was high baseline prevalence of triptan contraindications, warnings, and high cardiovascular risk, with a combined 46.2% meeting one or more of these criteria. Acute medication overuse was also common (25.1%) prior to rimegepant initiation. Results were consistent in the Optum database.

Our analysis provides the first real-world data available on tablet utilization and characteristics of new users of rimegepant.

Rimegepant is an oral small‐molecule calcitonin gene‐related peptide antagonist for acute migraine treatment with or without aura and prevention of episodic migraine in adults. This was a rimegepant single‐ and multiple‐dose phase 1, randomized, placebo‐controlled, double‐blind study to evaluate the pharmacokinetics and confirm safety in healthy Chinese participants. Participants received a 75‐mg rimegepant orally disintegrating tablet (ODT) (N = 12) or matching placebo (N = 4) ODT on days 1 and 3–7 after fasting for pharmacokinetic assessments. Safety assessments included 12‐lead electrocardiograms, vital signs, clinical laboratory data, and adverse events (AEs). After a single dose (9 females, 7 males) median time to maximum plasma concentration was 1.5 hours; mean values were 937 ng/mL (maximum concentration), 4582 h*ng/mL (area under the concentration–time curve, 0 to infinity), 7.7 hours (terminal elimination half‐life), and 19.9 L/h (apparent clearance). Similar results were seen after 5 daily doses, with minimal accumulation. Six (37.5%) participants experienced ≥1 treatment‐emergent AE: 4 (33.3%) had received rimegepant and 2 (50.0%) had received placebo. All AEs were grade 1 and resolved by the end of the study with no deaths, serious/significant AEs, or AEs leading to discontinuation. Overall, single‐ and multiple‐dose rimegepant ODT 75 mg was safe and well‐tolerated in healthy Chinese adults with similar pharmacokinetics to non‐Asian healthy participants.Trial registration: This trial is registered with the China Center for Drug Evaluation (CDE): CTR20210569