FDA approves Sofdra for hyperhidrosis treatment

Botanix Pharmaceuticals has achieved a significant milestone with the approval of Sofdra (sofpironium) gel, 12.45%, by the US Food and Drug Administration (FDA) for treating excessive underarm sweating, known as primary axillary hyperhidrosis. This treatment is authorized for both adults and children aged nine years and older. Notably, Sofdra is the first new chemical entity approved in the United States specifically for this condition.

The FDA’s approval was influenced by data from two Phase III clinical trials, known as the CARDIGAN studies, which involved 701 participants. These trials compared the effectiveness and safety of Sofdra against a placebo in individuals suffering from primary axillary hyperhidrosis. The results were promising, as Sofdra met all of its primary and secondary endpoints. Significant improvements were observed in both Gravimetric Sweat Production (GSP) and the Hyperhidrosis Disease Severity Measure-Axillary, 7-item (HDSM-AX7) score from baseline measurements.

Botanix Pharmaceuticals plans to introduce an early patient experience program in the third quarter of 2024. This initiative will enable eligible patients to gain early access to Sofdra, supported by telemedicine services and assistance with payer reimbursement. The broader commercial launch of the treatment is expected to occur in early Q4 2024.

Dr. Howie McKibbon, CEO of Botanix, expressed his satisfaction with the FDA approval, acknowledging the contributions of the Botanix team, dermatologists, clinical study participants, and shareholders who made this achievement possible. He highlighted this event as a transformative moment for the company, marking its transition from a development-focused entity to a revenue-generating dermatology firm.

Executive Chairman Vince Ippolito also emphasized the significance of this development, noting that Sofdra offers a novel therapeutic option for the approximately 10 million individuals in the United States affected by primary axillary hyperhidrosis. As a unique new chemical entity, Sofdra provides dermatologists with an innovative approach to managing this debilitating medical condition.

In summary, the FDA's approval of Sofdra gel represents a crucial advancement in the treatment of primary axillary hyperhidrosis. With its early access program and forthcoming commercial launch, Botanix Pharmaceuticals is poised to make a substantial impact on the lives of those affected by this condition.