Sofpironium bromide gel reduces severity of axillary hyperhidrosis

Sofpironium bromide gel reduced hyperhidrosis severity and demonstrated an acceptable safety profile in a phase 2 study detailed in Journal of the American Academy of Dermatology.

Hyperhidrosis affects approximately 4.8% of the population in the United States.

The multicenter, randomized, controlled, double-blind study included 225 participants who were randomly assigned into one of four treatment groups: sofpironium bromide gel 5%, 10% or 15% or vehicle. Patients had a washout period of 35 days and were given active gels containing sofpironium bromide or vehicle in identical metered-pump containers. They were instructed to apply one full pump, or 0.56 g, of the gel once per day at bedtime to each axilla for 42 days.

Each sofpironium bromide treatment group experienced meaningful differences in Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score from baseline to the end of treatment. Those in the 5% group had a mean change (standard error) of –2.02 (0.14), while those in the 10% group had a change of –2.09 (0.14) and those in the 15% group had a –2.10 (0.14) change. The vehicle group had a change of –1.30 (0.14). The changes in the sofpironium bromide groups were statistically significant compared with the vehicle group (P .0001).

“Although the vehicle group exhibited notable improvements in HDSM-Ax, as has been observed in other hyperhidrosis treatment trials using patient-reported outcomes, the active-treatment groups exhibited clinically meaningful differences relative to placebo,” the study authors wrote.

While all treatment groups experienced a mean reduction in gravimetric sweat production vs. vehicle, only the 15% group “met the prespecified criterion for a meaningful positive signal vs. the vehicle group,” according to the study.

Seventy-three participants reported 177 treatment-emergent adverse events, with 104 of those events considered to be possibly related to the treatment.

“The novel anticholinergic drug sofpironium bromide, applied to the axillae in a topical gel formulation containing 5%, 10% or 15% active drug, induced clinically signicant and statistically meaningful reductions in hyperhidrosis severity according to three patient-reported outcome measures,” the authors wrote. – by Rebecca L. Forand

Disclosures: Kirsch reports he was formerly the medical director and vice president of clinical development for Brickell Biotech. Please see the study for all other authors’ relevant financial disclosures.