BBI - Brickell Biotech launches late-stage study with sofpironium topical gel for excessive sweating

Brickell Biotech (BBI) has initiated its first U.S. Phase 3 (Cardigan I) study evaluating sofpironium bromide gel, 15% as a potential treatment for primary axillary hyperhidrosis (abnormally excessive sweating in underarms).The 350-subject study will evaluate the safety and efficacy of the gel. Subjects will apply the investigational product once daily for 6 consecutive weeks, with a 2-week post-treatment follow-up. Co-primary efficacy endpoints include the proportion of subjects achieving at least a 2-point improvement on the disease severity scale, and change in gravimetric sweat production, each from baseline to end of treatmentLast month, Brickell’s Japanese development partner, Kaken Pharmaceutical received regulatory approval for sofpironium bromide gel, 5% for the same indication.

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Brickell Biotech launches late-stage study with sofpironium topical gel for excessive sweating