Botanix Gets FDA Approval for Hyperhidrosis Medication

The FDA has approved Sofdra (sofpironium) gel for the treatment of severe underarm perspiration, according to otanix Pharmaceuticals.

Both adults and kids nine years of age and older are eligible to use the therapy.

The sole novel chemical entity to be approved for this ailment in the US is Sofdra.

Based on the findings of the two Phase III CARDIGAN trials including 701 people, the FDA made its judgement.

In Q3 of 2024, Botanix will launch an early consumer experience initiative that will provide qualifying patients early use of Sofdra.

Botanix CEO Dr Howie McKibbon commented: “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.

He contimued: “This is a transformative event for Botanix as we transition from a development stage to a revenue-generating dermatology company.”