Sofpironium Bromide Gel Is Safe & Effective in Primary Axill
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Sofpironium bromide is a retro-metabolically designed analog of glycopyrrolate (anticholinergic) in development for the topical treatment of primary axillary hyperhidrosis. Retro-metabolically designed drugs are intended to be rapidly metabolized in the bloodstream, potentially allowing for optimal therapeutic effect at the site of application with minimal systemic side effects.

A Study was conducted to evaluate the long-term safety, tolerability and pharmacokinetics of topically applied sofpironium bromide gel, 15% for the treatment of axillary hyperhidrosis in pediatric subjects, as well as to explore efficacy.

21 subjects with primary axillary hyperhidrosis of more than 6 months duration ranging in age from 9 to 16 years, who had participated in and completed a previous 1-week safety and pharmacokinetic (PK) study, were enrolled and treated with sofpironium bromide gel, 15% applied to the axillae for 24 weeks.

--The mean age (SD) of the subjects was 13.3 (2.29) years.
--16 subjects completed 24-weeks of treatment.
--7 subjects had treatment emergent adverse events (TEAEs). --4 subjects had TEAEs that were considered related to study drug, which included expected systemic anticholinergic effects (blurred vision, dry mouth, dry eyes, mydriasis) and local site reactions (pain, pruritus, rash, erythema).
--2 subjects discontinued the study due to adverse events, which included dry eye, dry mouth, pruritus and rash.
--The majority of subjects did not have any local signs or symptoms and none were severe.

Pharmacokinetic analysis did not show any evidence of sofpironium or BBI-4010 (major metabolite) accumulation, with most subjects having plasma concentrations that were not quantifiable. For the validated patient-reported outcome measure Hyperhidrosis Disease Severity Measure-Axillary (HDSMAx), the mean (SD) change from baseline (from study BBI-4000-CL105) to Week 24 of this study was -1.91 (1.038). A change of -1.00 represents clinically meaningful improvement.

Conclusively, 15% seem healthy and generally well tolerated in the 24-week trial in the pediatric population for sofpironium bromide gel. There were no TEAEs and there were no extreme or serious AEs in most of the subjects. No proof of drug accumulation exists. Axillary hyperhidrosis was clinically substantially improved.