Indexed on: 14 Jul '18Published on: 14 Jul '18Published in: Journal of The American Academy of Dermatology
Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis. Assess the efficacy and safety of GT for primary axillary hyperhidrosis. ATMOS-1 and ATMOS-2 were replicate randomized, double-blind, vehicle-controlled, 4-week phase 3 trials. Patients were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. Coprimary endpoints were responder rate (≥4-point improvement from Baseline) on Item 2 (sweating severity) of the Axillary Sweating Daily Diary (ASDD), a newly developed patient-reported outcome, and absolute change from Baseline in axillary gravimetric sweat production at Week 4. Safety evaluation included treatment-emergent adverse events (TEAEs). Pooled data, consistent with individual trial results show significantly more GT-treated patients achieved ASDD Item 2 response versus vehicle (59.5% vs 27.6%) and had reduced sweat production from Baseline (-107.6mg/5min vs -92.1mg/5min) at Week 4 (P<0.001 for both coprimary endpoints). Most TEAEs were mild or moderate and infrequently led to discontinuation. Short trial duration and inherent challenges in gravimetrically assessing sweat production. Daily, topically-applied GT over 4 weeks reduced sweating severity as measured by ASDD-Item 2, reduced sweat production as measured gravimetrically, and was generally well tolerated in primary axillary hyperhidrosis patients. Copyright © 2018. Published by Elsevier Inc.