Post Hoc Subgroup Analyses of the Efficacy and Safety of Zavegepant for the Acute Treatment of Migraine According to Baseline Triptan Experience.

INTRODUCTION

Zavegepant is a small-molecule calcitonin gene-related peptide receptor blocker (gepant). Gepants may be particularly useful in people who are triptan insufficient responders (TIR) and/or have contraindications for use of triptans.

METHODS

Post hoc analyses of efficacy and safety from the development program for zavegepant 10 mg nasal spray for the treatment of acute migraine in adults by baseline triptan experience. Pooled efficacy data from two double-blind, single-dose, randomized, placebo-controlled trials (NCT03872453, NCT04571060) were used to assess efficacy; co-primary efficacy endpoints were pain freedom (2 h PF) and most bothersome symptom (2 h MBS) freedom at 2 hours post-dose. Safety assessments included adverse events (AEs) from the 1-year, multiple-dose, open-label study (NCT04408794). Participants were grouped based on triptan use into a triptan naïve group (never used a triptan), TIR (used ≥1 triptans but not currently on a triptan), and current triptan users.

RESULTS

Overall, 2061 (pooled efficacy analysis set) and 603 (long-term safety analysis set) participants were included. In pooled analyses, 2 h PF rates for zavegepant versus placebo were 21.0% versus 11.9% (p=0.0254) for current triptan users, 24.8% versus 17.4% (p=0.0029) for triptan-naïve, and 21.8% versus 12.6% (p=0.0024) for TIR. For 2 h MBS freedom, corresponding rates were 40.0% versus 29.5% (p=0.0440), 40.4% versus 34.0% (p=0.0303), and 41.0% versus 29.9% (p=0.0035). In long-term safety analyses, incidences of AEs, serious AEs, and AEs leading to discontinuation were generally consistent across subgroups, regardless of triptan experience.

CONCLUSION

In these post hoc analyses, response rates favored zavegepant versus placebo for the acute treatment of migraine, regardless of triptan experience. Zavegepant was well tolerated.