Sofpironium bromide is a new molecular entity that recently underwent testing in a confirmatory randomized, double-blind, vehicle-controlled Phase 2b clinical trial in patients with primary axillary hyperhidrosis (excessive underarm sweating). In this study, sofpironium bromide was well-tolerated and achieved statistically significant results in 227 subjects with axillary hyperhidrosis. Based upon these positive Phase 2b results, we initiated the Phase 3 Long-Term Safety Study for sofpironium bromide gel in September 2018 (the “Argyle Study”) and intend to commence the Pivotal Phase 3 program in the fourth quarter of 2019.
Topical soft anticholinergic for axillary hyperhidrosis
Sofpironium bromide is a new molecular entity and “soft” drug that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system and are responsible for a range of bodily functions, including the activation of sweat glands. Soft drugs, such as sofpironium bromide, exert their action topically and are rapidly metabolized once absorbed into the blood. This mechanism of action may allow for effective doses to be used while reducing the limiting systemic side effects associated with other drugs in this class.
Sofpironium bromide was specifically developed to treat primary axillary hyperhidrosis as a potential self-administered, easy to apply, safe topical treatment alternative. Based upon clinical trial results to date, sofpironium bromide, if approved, could represent a meaningful novel treatment option for the more than 15 million Americans living with hyperhidrosis.