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.”
