- Botanix Pharmaceuticals (BOT) accelerates the submission of a New Drug Approval (NDA) for its Sofpironium Bromide gel to be ready to file in Q3 2022
- To coincide with the acceleration, Botanix has ramped up its commercial launch activities and is advancing several manufacturing activities required for FDA application
- Sofpironium Bromide is a topically administered therapy that is applied once daily to treat excessive underarm sweating
- Botanix has also completed enrollment for a rosacea phase 1/2 clinical study and a canine dermatitis pilot study, both on track for completion in Q3 2022
- Shares in Botanix are up 10.17 per cent and are trading at 6.5 cents each at 11:52 am AEST
Botanix Pharmaceuticals (BOT) has accelerated the submission of a New Drug Approval (NDA) for its Sofpironium Bromide gel to be ready to file in Q3 2022.
To coincide with the acceleration, Botanix has ramped up its commercial launch activities and is advancing several manufacturing activities required for US Food and Drug Administration (FDA) application.
Sofpironium Bromide is a topically administered therapy that is applied once daily to treat primary axillary hyperhidrosis — a condition causing excessive underarm sweating.
The treatment is designed to bind to a receptor and subsequently block the sweat signal, and roughly 85 per cent of patients under a phase three trial experienced a clinical improvement in their condition.
“Our team has worked very hard since the acquisition in May to finalise the dossier for submission to the FDA for approval of Sofpironium Bromide, with only the formatting and publishing remaining to be completed before being ready to submit the NDA filing this quarter,” Botanix President and Executive Chair Vince Ippolito said.
“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.”
Botanix has also completed enrollment for a rosacea phase 1/2 clinical study and a canine dermatitis pilot study which are both on track for completion in Q3 2022.
Treatments will be administered over the coming weeks with the outcomes to be reported to the market shortly after.
Shares in Botanix were up 10.17 per cent and are trading at 6.5 cents each at 11:52 am AEST.