The Company developing treatments for skin infections and diseases, Botanix Pharmaceuticals (ASX: BOT), has filed a New Drug Application (NDA) submission with the US Food and Drug Administration (FDA) for its Sofpironium Bromide product.
The submission will seek FDA approval for the treatment of primary axillary hyperhidrosis.
Hyperhidrosis is a rare disorder characterised by excessive sweating on the palms of the hands, feet, armpits, groin area, and under the breasts.
It is estimated that 7.3 million people across the US alone carry the disorder. Of these 7.3 million individuals, approximately 3.7 million have been actively seeking treatment.
The submission follows successful and significant results from the Phase 3 Cardigan I and II clinical studies. More than 700 patients were enrolled in the two Phase 3 studies, and 300 patients participated in a separate 48-week safety study of Sofpironium Bromide.
Based on the results from the trials, the Company believes that its Sofpironium Bromide medication has the potential to be one of the best in class for treating axillary hyperhidrosis.
The FDA usually has an assessment period of 12 months, where Botanix is targeting approval of its NDA by December 2023.
Sofpironium Bromide has recently been approved for sale in Japan, where the Company has witnessed outstanding early sale results achieved following the approval. Botanix is hoping to replicate these results in the US, which is considered a massively undersaturated market when treating this disorder.
“We are delighted with the achievement of this submission milestone,” said President and Executive Chair of Botanix, Vince Ippolito.
“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.”
As announced in their FY22 Annual Report, Botanix reported a loss of $13.2 million, climbing from a loss of $3.3 million over the previous corresponding period. BOT shares popped 5% on open today to sit on $0.065 at the time of writing, but this follows a two-year downtrend from its highs of $0.29 in June 2019.
Trading Desk Assistant at Emerald Financial
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