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FDA Approves Sofpironium Gel for Primary Axillary Hyperhidrosis

The U.S. Food and Drug Administration has approved sofpironium topical gel, 12.45% (Sofdra, Botanix)  for primary axillary hyperhidrosis in adults and children aged nine and older.

The FDA approval was supported by results  from the two pivotal Phase 3 ‘CARDIGAN’ studies which evaluated the efficacy  and  safety  of Sofdra versus vehicle and enrolled 701 patients  with primary axillary hyperhidrosis. In the studies, 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 approval of Sofdra is terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options,” says David  Pariser, MD, founding  board  member  of  the International Hyperhidrosis  Society  and  Past  President  of  the American  Academy  of  Dermatology, 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.”

Roll-out plans

An early patient experience program is planned to be launched by the Company in Q3 CY2024 to enable patients to gain early access to Sofdra. These patients will be guided through the telemedicine and payer reimbursement process to be the first commercial users of the product.  A Broader launch of Sofdra is expected to follow in early Q4 CY2024.

“We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the United States,” adds Botanix Executive Chairman Mr. Vince Ippolito. “As  the  first  and  only  new  chemical  entity,  Sofdra  represents  a  new  therapeutic  approach  for dermatologists to treat patients with this disabling medical condition.”