Botanix has acquired the rights for a novel product called Sofpironium Bromide, a drug in development for the treatment of primary axillary hyperhidrosis, where excessive sweating occurs beyond what is needed to maintain normal body temperature. The product has promising potential as a best-in-class solution, backed by positive results from a Phase 3 pivotal clinical program, and has already been approved in Japan and launched by Botanix’s partner Kaken Pharmaceutical Co., Ltd. (Ecclock®️ Sofpironium Bromide 5%).
Sofpironium Bromide is a new chemical entity for which Botanix is preparing to submit a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA) as a self-administered, once-daily, topical gel therapy in 2H 2022.
Sofpironium Bromide is an anticholinergic/antimuscarinic drug that blocks sweating at the gland by binding to the receptor and thereby blocking the sweat signal. Sofpironium Bromide is delivered to the underarms as a gel formulation using a patented applicator that allows the patient to avoid direct contact with the drug on their hands. Approximately 85% of patients using Sofpironium Bromide gel 15% experienced a clinically meaningful improvement in their condition over the course of the Phase 3 studies.
Positive results from Phase 3 clinical studies were reported in late 2021 for Sofpironium Bromide, with all primary and secondary endpoints achieving statistical significance. More than 700 patients were enrolled in the two Phase 3 studies and approximately 300 patients participated in a 48-week safety study of Sofpironium Bromide. There were no treatment related serious adverse events in any of the studies and adverse events were transient and mild to moderate in nature.