Clinical dermatology company Botanix Pharmaceuticals (ASX:BOT) has announced that the US FDA has approved Sofdra (sofpironium).
Sofdra is a prescription medicine for primary axillary hyperhidrosis (excessive underarm sweating) in adults and children nine years and older.
Botanix said it is the first and only new chemical entity approved by the FDA to treat primary axillary hyperhidrosis and presents a novel, safe and effective solution for patients who have lacked treatment options for this socially challenging medical condition.
Botanix CEO Dr Howie McKibbon said, “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.”
Hyperhidrosis is characterised by abnormally increased sweating beyond that required to regulate body temperature. The disproportionate sweat production results in a disabling medical condition with profound effects on the patient’s quality of life. Hyperhidrosis affects work productivity, daily routine activities, emotional well-being, and personal relationships. It is the third largest dermatology condition, with approximately 10 million patients in the US.
Botanix said 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 company said it will launch a patient experience program ahead of a broader commercial launch in the early fourth quarter of 2024.
Executive Chairman Vince Ippolito said, “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.”
The company said it would remain at a halt pending an announcement of the results of a potential capital raising, which is expected no later than the opening of trading on 21 June 2024.