Good results seen with sofpironium bromide gel in Japanese patients with hyperhidrosis

Sofpironium bromide gel reduced hyperhidrosis with few adverse events in Japanese patients, according to findings from a phase 3 study presented at the American Academy of Dermatology virtual meeting.

Hiroo Yokozeki, MD, PhD, of Tokyo Medical and Dental University in Japan, and colleagues examined the safety and efficacy of topical sofpironium bromide gel 5% in Japanese patients with hyperhidrosis.

The researchers evaluated the data of 270 participants older than age 12 years from a randomized, double-masked vehicle-controlled study who applied either sofpironium bromide gel 5% or vehicle during a 42-day period. The participants had Hyperhidrosis Disease Severity Scale (HDSS) scores greater than 3, Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scores greater than 2 and gravimetric sweat production (GSP) per axilla of 50 mg per 5 minutes or greater.

“HDSM-Ax is the subjective symptoms of primary axillary hyperhidrosis and is a newly developed index based on FDA guidance,” Tomoko Fujimoto, MD, PhD, of the department of dermatology at Tokyo Medical and Dental University, said in the presentation.

HDSS scores less than 2 and a decrease of GSP greater than 50% occurred in 53.9% of subjects in the sofpironium bromide group compared with 36.4% in the vehicle group (P < .003). GSP reduction at the end of treatment was –157.6 mg in the sofpironium bromide group compared with –127.6 mg in the vehicle group (P < .015). The sofpironium bromide group had a greater change in HDSM-Ax at the end of treatment (–1.41) compared with the vehicle group (–0.93) (P < .001).

Mild anticholinergic adverse events were found in three subjects in the sofpironium bromide group and resolved spontaneously.

“The events with high incidence reported from the sofpironium group include nasal pharyngitis, application site dermatitis and application site edema,” Fujimoto said. “This might indicate a possible inference of sofpironium, but the majority of events were mild and did not pose any issues in continued use of sofpironium.”