Sofpironium topical gel, 12.45%, for the treatment of axillary hyperhidrosis: pooled efficacy and safety results from 2 phase 3 randomized, controlled, double-blind studies.

Abstract

Background: Current treatments for primary axillary hyperhidrosis are insufficient for some patients. Sofpironium topical gel is a retrometabolically-designed topical anticholinergic with rapid metabolism, which is associated with reduced side effects and targeted efficacy.

Objective: To assess efficacy and safety of sofpironium topical gel for primary axillary hyperhidrosis.

Methods: Cardigan I and Cardigan II were double-blind, randomized, controlled pivotal phase 3 studies of sofpironium topical gel, 12.45%, versus vehicle gel (1:1 randomization) for daily application to the axillae for 6 weeks.

Results: The combined Phase 3 studies included 353 subjects in the treatment groups and 348 subjects in the control groups. For the co-primary endpoint of ≥2-point improvement from baseline to end of treatment on Hyperhidrosis Disease Severity Measure-Axillary-7, pooled analyses showed significantly better results for treatment versus control (p<0.0001). For the pooled co-primary endpoint of gravimetric sweat production at treatment end, the treatment group had greater reduction in sweat production (p=0.0002). Secondary endpoints also showed a statistically significant benefit for sofpironium topical gel versus control. Treatment was well-tolerated.

Limitations: Short treatment and follow-up periods.

Conclusion: Sofpironium topical gel, 12.45%, applied topically once daily before bedtime is effective and well-tolerated for treatment of primary axillary hyperhidrosis in patients ≥9 years old.