The US Food and Drug Administration (FDA) has approved a new prescription gel used to treat axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 and older, manufacturer Botanix Pharmaceuticals announced.

Sofdra (sofpironium) is the first chemical entity approved by the FDA to treat primary axillary hyperhidrosis and “presents a novel and effective solution for patients who have lacked treatment options for this socially challenging medical condition,” the company said in a press release.

“The approval of Sofdra is terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options,” David Pariser, MD, founding board member of the International Hyperhidrosis Society and Past President of the American Academy of Dermatology, said in the press release. “The availability of a new treatment alternative that is topical, well-tolerated, effective, and easy to use is truly exciting and would be welcomed amongst patients and physicians.”

The FDA approval was supported by results from two pivotal Phase 3 “CARDIGAN” studies that evaluated the efficacy and safety of Sofdra versus vehicle. In the studies, which included 701 patients with the condition, treatment with Sofdra successfully met all primary and secondary endpoints with clinically and statistically meaningful changes from baseline in Gravimetric Sweat Production (GSP) and the Hyperhidrosis Disease Severity Measure-Axillary, 7-item (HDSM-AX7) score.

The company said an early patient experience program is planned for the third quarter of 2024 in Germany. Highly qualified patients will gain early access to Sofdra and will be guided through the telemedicine and payer reimbursement process. Broader launch of Sofdra is expected in the fourth quarter.

“We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the United States,” Botanix Executive Chairman Vince Ippolito said in the press release.