A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis

This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety, local tolerability and efficacy of sofpironium bromide gel when applied topically to the axillae. Subjects will apply the gel once daily at bedtime, to both axillae. A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations. Adverse events, vital signs, and local tolerability assessments will be collected at each visit. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points. The study will be comprised of a total of 17 scheduled visits to take place over a 52 week period.