Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials

Abstract

GT applied topically on a daily basis over 4 weeks reduced the severity of sweating as measured by ASDD-Item 2, reduced sweat production as measured gravimetrically, and was generally well tolerated in patients with primary axillary hyperhidrosis.

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

“…These subgroup data are consistent with previous findings of individual and pooled ATMOS‐1 and ATMOS‐2 data showing that GT improved disease symptoms, severity, and quality of life vs vehicle . ASDD/ASDD‐C Item 2 responder rates were nearly identical among GT‐treated pediatric and older subgroup patients.…”

“…Identical excipients were included in the vehicle comparator of the ATMOS trials to account for any potential effect due to a compound other than active drug. Though a vehicle effect was observed in these trials, GT‐treated patients had a significantly greater response than that observed with vehicle …”

“…ATMOS‐1 (US and Germany sites) and ATMOS‐2 (US sites only) assessed the efficacy and safety of GT vs vehicle when applied once‐daily for 4 weeks (Figure ). A detailed description of trial methodology and approval by local institutional review boards have been reported . Patients were assessed in clinics at Weeks 1, 2, 3, and 4 (end of treatment).…”

“…Detailed inclusion and exclusion criteria are fully reported in the primary publication . Briefly, patients were male or nonpregnant females ≥ 9 years of age (≥ 18 years in Germany) with primary axillary hyperhidrosis for ≥ 6 months, gravimetrically measured sweat production ≥ 50 mg/5 min in each axilla, Axillary Sweating Daily Diary (ASDD)/ASDD‐Children (ASDD‐C) axillary sweating severity item (Item 2) ≥ 4 (11‐point scale), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3 (4‐point scale).…”

“…GT is applied once–daily to the axillae using a premoistened towelette. GT‐treated patients had decreased sweating severity and sweat production, with improvements in quality of life vs vehicle‐treated patients in two randomized, double‐blind vehicle‐controlled, pivotal phase three studies for primary axillary hyperhidrosis (ATMOS‐1, N = 344 [NCT02530281] and ATMOS‐2, N = 353 [NCT02530294]) . ATMOS‐1 and ATMOS‐2 were the first randomized, controlled phase three trials in primary axillary hyperhidrosis to enroll pediatric patients, offering a unique perspective into this underserved population.…”