FDA approval date in our sights
Botanix’s lead product is Sofdra™ (sofpironium bromide) gel, 15%, a drug in development for the treatment of primary axillary hyperhidrosis, where excessive sweating occurs beyond what is needed to maintain normal body temperature. Sofdra gel is a new chemical entity for the treatment of primary axillary hyperhidrosis for which Botanix has successfully submitted a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA). We expect FDA approval in mid-2024.
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%).
Sofdra gel 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 drug contact with their hands. Approximately 85% of patients using Sofdra gel experienced a clinically meaningful improvement in their condition over the course of the Phase 3 studies.
Positive results from Phase 3 clinical studies were accomplished for Sofdra gel, 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 long-term safety study of Sofdra gel. 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
Sofdra (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 1 and Cardigan 2. The studies were multi-center, randomised, double-blinded, vehicle (placebo)-controlled, evaluating the efficacy and safety of topically applied Sofdra gel. Each Cardigan study enrolled approximately 350 subjects nine years of age and older for the treatment of primary axillary hyperhidrosis, and subjects applied Sofdra gel or placebo to their underarms once daily at bedtime for six consecutive weeks, with a two-week post-treatment follow-up.
