- Botanix Pharmaceuticals (BOT) submits a new drug application (NDA) to the US FDA for the use of its sofpironium bromide gel for patients with severe primary axillary hyperhidrosis
- The company says it is targeting FDA approval for the fourth quarter of 2023, provided the application follows a typical 12-month assessment and review period
- The FDA filing comes after Botanix’s sofpironium bromide product was approved for sale in Japan, with “outstanding” early sales already achieved, according to the company
- The company says it will now look for other opportunities to bolster its product pipeline with more late-stage or revenue-producing dermatology products
- Shares in Botanix are up 6.45 per cent to 6.6 cents at 11:01 am AEST
Botanix Pharmaceuticals (BOT) has submitted a new drug application (NDA) to the FDA for the commercial sale of its sofpironium bromide gel.
The gel is designed to treat primary axillary hyperhidrosis, which Botanix said affected over seven million people in the US alone.
The company said it was targeting FDA approval for the product in the fourth quarter of 2023, provided the application followed a typical 12-month assessment and review period.
The submission follows successful results from Botanix’s phase three trials of the product, which demonstrated “highly statistically significant clinical efficacy and excellent safety”.
Moreover, the product has already been approved for sale in Japan, with “outstanding” early sales already achieved.
Botanix President and Executive Chair Vince Ippolito said the FDA submission was a milestone for the company.
“Approximately 7.3 million people in the US suffer from hyperhidrosis and have the potential to benefit from sofpironium bromide,” Mr Ippolito said.
“We look forward to working closely with the FDA on the approval of sofpironium bromide.”
The company said looking ahead, it now planned to pursue other opportunities to bolster its product pipeline with additional late-stage or revenue-producing dermatology products.
Earlier this month, the company raised $7.5 million via a share placement to fund the costs associated with the sofpironium bromide FDA filing.
Shares in Botanix were up 6.45 per cent to 6.6 cents at 11:01 am AEST.