Safety of Rimegepant in Patients Using Preventive Migraine Medications: A Subgroup Analysis of a Long-Term, Open-Label Study Conducted in the United States

Abstract

Gary Berman,1 Alexandra Thiry,2 Robert Croop3 1Clinical Research Institute, Minneapolis, MN, USA; 2Pfizer Inc., New York, NY, USA; 3Biohaven Pharmaceuticals, New Haven, CT, USACorrespondence: Gary Berman, Clinical Research Institute, 825 Nicollet Mall Suite 1135, Minneapolis, MN, 55402, USA, Tel + 1 612-333-2200, Email [email protected]: To evaluate the safety and tolerability of rimegepant 75 mg for the acute treatment of migraine in participants concurrently using a preventive migraine medication.Patients and Methods: This long-term, open-label safety study (NCT03266588) enrolled adults with a history of 2– 14 moderate or severe migraine attacks per month. Participants self-administered rimegepant 75 mg (1) up to once daily as needed for 52 weeks to treat attacks of any pain intensity or (2) every other day plus as needed for 12 weeks. Preventive migraine medications were allowed if dosing was stable for ≥ 2 months prior to the baseline visit.Results: Of 1800 rimegepant-treated participants, 243 (13.5%) took a concomitant preventive medication. The most common preventive medication was topiramate (26.3%). Rimegepant exposure was comparable in both groups (mean [SD] number of doses per 4 weeks was 7.8 [4.5] in those taking preventives and 7.7 [4.7] in those not taking preventives). The proportion of participants experiencing ≥ 1 on-treatment adverse event (AE) was 68.7% among those using preventive medication and 59.2% among those not using preventives. Serious AEs occurred in 4.5% of those using preventive medication and 2.3% of those who were not using preventives. AEs leading to study drug discontinuation occurred in 4.5% of those taking preventive medication and 2.4% of those not taking preventives. AEs occurring in ≥ 5% of participants in either cohort (with preventives vs without preventives) were upper respiratory tract infection (7.4% vs 9.0%), nasopharyngitis (7.8% vs 6.6%), sinusitis (7.0% vs 4.8%), urinary tract infection (5.3% vs 3.6%), and back pain (5.3% vs 2.8%).Conclusion: Acute treatment of migraine with rimegepant 75 mg for up to 52 weeks was well tolerated and had a favorable safety profile in adults who were concomitantly using preventive migraine medication.Keywords: rimegepant, migraine, preventive, concomitant, safety, clinical trial

Keywords

• rimegepant
• migraine
• preventive
• concomitant
• safety
• clinical trial.