Botanix Pharmaceuticals has announced the receipt of approval from the US Food and Drug Administration (FDA) for Sofdra (sofpironium) gel, 12.45%, for excessive underarm sweating (primary axillary hyperhidrosis).

The treatment is indicated for usage in adults and children aged nine years and above.

Sofdra is the first and only new chemical entity to receive approval in the US  for this condition.

The FDA’s decision was based on the results from the two Phase III CARDIGAN studies in 701 patients.

The trials assessed the efficacy and safety of Sofdra versus vehicle in primary axillary hyperhidrosis patients.

Sofdra met all primary and secondary endpoints, demonstrating significant changes from baseline in Gravimetric Sweat Production (GSP) and the Hyperhidrosis Disease Severity Measure-Axillary, 7-item (HDSM-AX7) score.

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Botanix will commence an early patient experience programme in the third quarter (Q3) of 2024, allowing qualified patients to obtain early access to Sofdra.

This programme will support patients through telemedicine and the payer reimbursement process, making them the first to use Sofdra commercially.

A broader launch is anticipated in early Q4 2024.

Botanix CEO Dr Howie McKibbon stated: “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.

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

Botanix executive chairman Vince Ippolito stated: “We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the United States.”

“As the first and only new chemical entity, Sofdra represents a new therapeutic approach for dermatologists to treat patients with this disabling medical condition.”