Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 Phase 3 Randomized Controlled Trials

Publication date: Available online 10 July 2018

Source: Journal of the American Academy of Dermatology

Author(s): Dee Anna Glaser, Adelaide A. Hebert, Alexander Nast, William P. Werschler, Lawrence Green, Richard Mamelok, Janice Drew, John Quiring, David M. Pariser

Abstract

Background

Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis.

Objective

Assess the efficacy and safety of GT for primary axillary hyperhidrosis.

Methods

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).

Results

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.

Limitations

Short trial duration and inherent challenges in gravimetrically assessing sweat production.

Conclusions

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.