ARTICLE | Clinical News

Brickell's sofpironium bromide meets in Phase IIb for hyperhidrosis

February 16, 2018 5:26 PM UTC

In October, Brickell Biotech Inc. (Boulder, Colo.) reported data from a double-blind, U.S. Phase IIb trial in 227 patients with primary axillary hyperhidrosis showing that 5%, 10% and 15% gel formulations of sofpironium bromide (BBI-4000) all met the primary endpoints of improving Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) from baseline to week six and of increasing the proportion of patients achieving a ≥1-grade improvement in HDSM-Ax vs. vehicle (p<0.0001 and p<0.001, respectively).

On secondary endpoints, all doses of sofpironium bromide significantly increased the proportion of patients achieving a ≥2-grade improvement in HDSM-Ax (p<0.001); a composite responder analysis, defined as a 50% reduction in gravimetric sweat production plus a 1- or 2-grade improvement in HDSM-Ax (p<0.0006 for 1-grade and p<0.002 for 2-grade); a 1- and 2-grade improvement in the Hyperhidrosis Disease Severity Scale (HDSS) (p<0.05 for 1-grade and p<0.005 for 2-grade); and Dermatology Life Quality Index (DLQI) score (p<0.004) vs. vehicle. Sofpironium bromide was well tolerated with no treatment-related serious adverse events reported...

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