Glycopyrronium Tosylate Phase 3 Clinical Program in Primary Axillary Hyperhidrosis
- In June 2016, Dermira reported data from ATMOS-1 and ATMOS-2, two identical Phase 3 multi-center clinical trials that evaluated the efficacy and safety of glycopyrronium tosylate 3.75% compared to vehicle in adolescent and adult patients (ages nine and older) with primary axillary hyperhidrosis.
- In the ATMOS-1 trial, 229 patients were randomized to receive glycopyrronium tosylate and 115 patients were randomized to receive vehicle; and in the ATMOS-2 trial, 234 patients were randomized to receive glycopyrronium tosylate and 119 patients were randomized to receive vehicle. Patients were instructed to apply the study product to each underarm once daily for four weeks using topical wipes containing either glycopyrronium tosylate or vehicle only.
- The co-primary endpoints were the proportion of patients who achieved at least a four-point improvement from baseline in sweating severity as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument, and the average absolute change from baseline in gravimetrically-measured sweat production.
- In both trials, the effect of treatment with glycopyrronium tosylate compared to vehicle, as measured by both ASDD and reduction in sweat production, were observed at week 1, and continued through week 4 of the 4-week trial.
- Glycopyrronium tosylate-treated patients began to see an improvement in sweating severity compared to vehicle, as measured by ASDD, at week 1 in ATMOS-1 (22.9% vs. 5.3%) and ATMOS-2 (29.0% vs. 4.2%), that continued through the completion of the 4-week treatment period.
- Patients also began to experience a reduction in gravimetrically-measured sweat production compared to vehicle beginning at week 1 in ATMOS-1 (-75.5 mg vs. -58.0 mg) and ATMOS-2 (-108.0 mg vs. -56.8 mg).