Botanix Pharmaceuticals accelerates filing of NDA

Latest News

Clinical dermatology company Botanix Pharmaceuticals (ASX:BOT) has announced the timing of the submission of the NDA for Sofpironium Bromide has been accelerated.

The company said the NDA will now be ready to be filed in the third quarter of 2022.

Botanix president and executive chair Vince Ippolito said, “Our team has worked very hard since the acquisition in May to finalise the dossier for submission to the FDA for approval of Sofpironium Bromidewith only the formatting and publishing remaining to be completed before being ready to submit the NDA filing this quarter.

“We are very excited by the opportunity that Sofpironium Bromide presents as the first and only new chemical entity to be developed for primary axillary hyperhidrosis.”

The company said it has also ramped up commercial launch preparation activities that need to be complete in anticipation of the product launch.

Sofpironium Bromide is a new chemical entity developed to be a once-daily, topically administered therapy for the treatment of primary axillary hyperhidrosis (excessive underarm sweating – a medical condition).

Sofpironium Bromide blocks sweating by binding to the receptor and thereby blocking the sweat signal, and recent Phase 3 studies demonstrated that approximately 85 per cent of patients using Sofpironium Bromide experienced a clinically meaningful improvement in their condition over the course of the studies.