Clinical dermatology company Botanix Pharmaceuticals (ASX: BOT) is preparing to submit a new drug application (NDA) for novel asset Sofpironium Bromide gel 15% for the treatment of excessive underarm sweating.
The application will go to the US Food and Drug Administration before the end of the September quarter and will be followed up with preparations for a commercial product launch post-approval.
Sofpironium Bromide has been developed as a best-in-class, once daily, topically-administered therapy for the treatment of a medical condition known as primary axillary hyperhidrosis (or excessive underarm sweating).
It is an anticholinergic/antimuscarinic drug delivered to the underarms in a gel formulation and blocks sweating at the gland by binding to the body’s receptor to stop the sweat signal.
It uses a patent-pending applicator which allows a patient to avoid direct contact with the drug.
Recent phase three studies demonstrated that approximately 85% of patients using the product experienced a “clinically meaningful improvement” in their condition.
Botanix acquired Sofpironium Bromide in May from US publicly-listed company Brickell Biotech Inc which developed the gel on the back of phase three pivotal work (including a 48-week safety study) late last year.
The novel dermatology asset is believed to be the world’s first and only new chemical entity to treat axillary hyperhidrosis, where excessive sweating occurs beyond what is needed to maintain normal body temperature.
The condition results from a physiological (not psychological) overstimulation of the nervous system and 80% of patients report its occurrence on more than one part of their body.
More than 15 million people in the US are believed to suffer from the condition, and approximately 77% report it has a negative impact on their lives.
Existing treatment options (including topical anti-perspirants, systemic oral drugs, Botox injections and surgery) have proven a lack of efficacy with poor side effect profiles.
Botanix president Vince Ippolito said Sofpironium Bromide would advance the company towards its goal of becoming a commercial dermatology specialist.
“Our team has worked very hard since May to finalise a dossier for submission to the US FDA [and we have] only the formatting and publishing to be completed before we are ready to submit the NDA this quarter,” he 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.”