Botanix submits NDA for FDA approval of Sofpironium Bromide
Botanix has today announced the submission of a New Drug Application to the FDA for approval of Sofpironium Bromide for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating).
Phase 3 studies of Sofpironium Bromide showed very high statistical significance for the treatment of primary axillary hyperhidrosis. In the US alone, there are approximately 7.3 million people who suffer from this disorder, with more than half of them actively seeking treatment.
Botanix President and Executive Chair, Vince Ippolito, said:
“We are delighted with the achievement of this submission milestone, and are targeting FDA approval in the US for 4Q CY2023 (following the usual 12-month FDA assessment and review period) to enable the commencement of sales in the US market.”
