FDA approval date in our sights
Botanix’s lead product is 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.
Sofpironium Bromide is a new chemical entity for which Botanix has successfully submitted a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA), and has received confirmation that it is suitable for substantive review – no issues have been identified.
We are currently preparing for the FDA’s mid-cycle review which is scheduled for 1Q 2023 which will serve to substantially de-risk the final approval for the product.
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 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.
Positive clinical results
As announced in October 2021, Sofpironium Bromide gel 15% achieved all of its primary and secondary endpoints with statistical significance in a US Phase 3 clinical program.
The US Phase 3 pivotal clinical program was comprised of two pivotal clinical studies, Cardigan I and Cardigan II. The studies were multi-center, randomised, double-blinded, vehicle (placebo)-controlled, evaluating the efficacy and safety of topically applied Sofpironium Bromide gel, 15%. Each Cardigan study enrolled approximately 350 subjects nine years of age and older for the treatment of primary axillary hyperhidrosis, and subjects applied Sofpironium Bromide gel, 15% or placebo to their underarms once daily at bedtime for six consecutive weeks, with a two-week post-treatment follow-up.