Assess the effects of rimegepant on migraine-related disability in adults with and without a history of triptan treatment failure.

Rimegepant is an orally administered small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist with demonstrated efficacy and safety in the acute and preventive treatment of migraine.

This was a long-term, open-label safety study (NCT03266588) of adults with a history of 2 to 14 moderate to severe monthly migraine attacks. Rimegepant was dosed as needed (PRN) for 52 weeks or every other day plus PRN on nonscheduled dosing days for 12 weeks. The Migraine Disability Assessment (MIDAS) was administered at baseline and weeks 12, 24, 36, and 52; disability was scored as 0-5 (little or no), 6-10 (mild), 11-20 (moderate), and ≥21 (severe). Subgroups with either no history of triptan failure (including triptan naive and current triptan users) or a history of failure with 1 or ≥2 triptans were assessed. Triptan failure was defined as having a history of discontinuing ≥1 triptan due to inadequate efficacy and/or poor tolerability.

Of the 1800 subjects, 546 (30.3%) had 1 triptan failure and 246 (13.7%) had ≥2 triptan failures. Baseline mean (SD) MIDAS total scores showed severe disability: 0 triptan failures 32.8 (33.1); 1 triptan failure 34.5 (31.8); and ≥2 triptan failures 36.9 (32.0). Changes from baseline in MIDAS total scores exceeded the clinically important difference threshold (defined as a mean reduction of MIDAS total scores ≥5) at weeks 12, 24, 36, and 52 for all 3 subgroups. At week 12, mean (95% CI) changes were −12.7 (−14.6, −10.8), −12.5 (−15.1, −10.0), and −12.0 (−15.9, −8.1) for subjects with 0 triptan failures (n=920), 1 triptan failure (n=498), and ≥2 triptan failures (n=220), respectively.

Rimegepant 75 mg reduced migraine-related disability based on reductions from baseline scores regardless of prior history of triptan treatment failure.