US FDA approves Botanix Pharma’s excessive underarm sweat drug

Botanix Pharmaceuticals (ASX:BOT) on Thursday described itself as having transitioned from a development stage to being revenue-generating dermatology company, following FDA approval for its product Sofdra.

Sofdra – sofpironium gel – has won FDA approval for use and sale in the US; the only product to treat excessive underarm sweating. The condition affects “approximately” 10M people in the US – 3% of the 333M population.

The drug works by jiggling around with the eccrine glands in the human body to reduce sweating. It was first discovered to be a workable product in Japan in 2020.

While Botanix had been touting a 15% gel, the FDA has approved a 12.45% concentration. The first ever approved product for the condition in Japan was lower at 5%.

With the company now able to market and sell the product in the US, the company anticipates first revenue in Q4 of CY2024.

While 10M people is only 3% of the US population, the cohort of people with excessive underarm sweat are, apparently, a powerful voice in the medical community. Take it from the President of the American Academy of Dermatology (AAD).

“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,” AAD President David Pariser said.

“The approval of Sofdra is terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options.”

BOT last traded at 34cps.