Botanix Pharmaceuticals submits new drug application to FDA

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Clinical-stage dermatology Botanix Pharmaceuticals (ASX:BOT) has submitted a New Drug Application (NDA) to the US FDA for the approval of sofpironium bromide for patients with severe primary axillary hyperhidrosis.

The company said the submission follows the successful results from the Phase 3 Cardigan clinical trials that demonstrated highly statistically significant clinical efficacy and safety.

According to Botanix president and executive chair Vince Ippolito, “We are delighted with the achievement of this submission milestone. Sofpironium Bromide has already been recently approved in Japan and achieved very strong early sales. Botanix is 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. Approximately 7.3 million people in the US suffer from hyperhidrosis and have the potential to benefit from Sofpironium Bromide. We look forward to working closely with the FDA on the approval of Sofpironium Bromide.”

Bromide Sofpironium Bromide is a topically applied gel. The company said it believes the treatment has the potential to be the best-in-class treatment for axillary hyperhidrosis. In the US alone, there are approximately 7.3 million subjects who suffer from severe primary axillary hyperhidrosis, which is the patient population in which the successful Phase 3 studies were conducted. Of those subjects, approximately 3.7 million subjects are actively seeking treatment.