FDA Approves Sofdra™ (sofpironium) Topical Gel 12.45% for Primarily Axillary Hyperhidrosis

The U.S. Food and Drug Administration (FDA) recently approved Botanix’s Sofdra™ (sofpironium) topical gel 12.45% for the treatment of primarily axillary hyperhidrosis in adults and children ages 9 and above.

Sofdra is the first and only chemical entity approved to treat primarily axillary hyperhidrosis (excessive underarm sweating) and is supported by results from the two pivotal Phase 3 CARDIGAN studies. These evaluated the safety and efficacy of Sodfra in 701 patients with primarily axillary hyperhidrosis compared to vehicle and demonstrated that approximately 85% of patients had significant improvement in hyperhidrosis symptoms. No serious adverse events related to the treatment were reported during the study and any mild to moderate adverse events were temporary.

"We are pleased to share this accomplishment with our dedicated Botanix team and dermatologist partners, patients who participated in the clinical studies and our shareholders who made this approval possible. This is a transformative event for Botanix as we transition from a development stage to a revenue generating dermatology company."

Sofpironium is intended for once-daily use with an applicator to avoid hand contact.

According to leading expert on hyperhidrosis, David Pariser, MD, who is also a founding board member of the International Hyperhidrosis Society and past President of the American Academy of Dermatology, “The approval of Sofdra is terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options,” said David Pariser, MD, in a news 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.”


Sign up to receive updates on educational opportunities, complimentary content, exclusive discounts, and more.