Phase III results show DRM 04 reduces impact and improves quality of life in pediatric hyperhidrosis.- Dermira.

Dermira has presented new findings from its DRM 04 (glycopyrronium tosylate) Phase III clinical program for pediatric patients (ages 9 to 16) with primary axillary hyperhidrosis. The data showed that when applied topically, the therapy improved disease severity, reduced sweat production and was associated with improved quality of life outcomes for pediatric patients with primary axillary hyperhidrosis, compared to vehicle-treated patients. Overall, 463 patients were randomized to glycopyrronium tosylate and 234 to vehicle. Of these, 44 were pediatric patients, ages 9 to 16 years of age (glycopyrronium tosylate, n=25; vehicle, n=19). Baseline disease characteristics were similar between age groups. Efficacy results were consistent among pediatric and adult patients.

Specifically, pooled Axillary Sweating Daily Diary (ASDD)/Children�s ASDD [ASDD-C] severity scale responder rates for pediatric vs. adult patients were 59.9% vs. 60.2% for glycopyrronium tosylate-treated and 13.0% vs. 28.8% for vehicle-treated patients, respectively. The median absolute changes in sweat production at week four for pediatric vs. adult patients were -64.2 mg vs. -80.6 mg for glycopyrronium tosylate-treated and -53.7 mg vs. -62.0 mg for vehicle-treated patients, respectively. The proportions of patients experiencing a reduction of at least 50 percent in sweat production at week four for pediatric vs. adult patients were 79.9% vs. 74.3% of glycopyrronium tosylate-treated and 54.8% vs. 53.0% of vehicle-treated patients, respectively. The mean decrease from baseline in the Children�s Dermatology Quality of Life Index was -8.1 for glycopyrronium tosylate-treated vs. -1.9 for vehicle-treated patients.

This is consistent with that observed for the Dermatology Life Quality Index measure observed for adults, -8.4 for glycopyrronium tosylate-treated vs. -4.7 for vehicle-treated patients. The rates of treatment emergent adverse events reported for pediatric vs. adult patients were 44.0% vs. 56.7% of glycopyrronium tosylate-treated and 10.5% vs. 34.3% of vehicle-treated patients, respectively. Most were related to anticholinergic activity and were mild, transient and infrequently led to drug discontinuation.These findings are consistent with results previously reported in adult patients (ages 17 and older). The data were featured during the Late-Breaking Research Forums at the 76th Annual Meeting of the American Academy of Dermatology.