Topical Agent for Hyperhidrosis Wins FDA Approval

The FDA approved sofpironium topical gel 12.45% (Sofdra) for primary axillary hyperhidrosis, according to a statement from Botanix Pharmaceuticals.

The approval stipulates use in adults and children 9 years or older. According to the company, the product is the first new chemical entity approved to treat primary axillary hyperhidrosis.

“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, of Pariser Dermatology Specialists in Norfolk, Virginia, and past president of the American Academy of Dermatology, in the statement. “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.”

Support for the approval came from two phase III trials (CARDIGAN) that compared topical sofpironium versus vehicle in a total of 701 patients with primary axillary hyperhidrosis. The trials met all primary and secondary endpoints, showing “clinically and statistically meaningful” improvement from baseline in Gravimetric Sweat Production and the Hyperhidrosis Disease Severity Measure-Axillary score.

The third most common dermatology condition (after acne and atopic dermatitis), hyperhidrosis affects an estimated 10 million people in the U.S. The sweat production associated with the condition exceeds normal requirements for body temperature regulation. Hyperhidrosis has disabling effects on some people, including work productivity, daily routine activities, emotional well-being, and personal relationships.

The company plans to launch an early access program during the third quarter of 2024, followed by a broader launch during the fourth quarter.

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