Positive results have been reported from two pivotal phase 3 trials of DRM04 (Dermira, Inc.), a topical anticholinergic product candidate in development for the treatment of patients with primary axillary hyperhidrosis (excessive underarm sweating). Both studies compared DRM04 with vehicle.
The ATMOS-1 and ATMOS-2 trials were designed as identical, randomized, double-blind, vehicle-controlled studies to assess the safety and efficacy of DRM04 at a concentration of 3.75% compared with vehicle in adolescent and adult patients (9 years of age and older) with primary axillary hyperhidrosis. The ATMOS-1 trial enrolled 344 patients at 29 sites in the United States and Germany, and the ATMOS-2 trial enrolled 353 patients at 20 sites in the U.S. The patients were instructed to apply the study product to each underarm once daily for four weeks using topical wipes containing either DRM04 or vehicle.
The coprimary endpoints in the ATMOS-1 and ATMOS-2 trials 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), and the average absolute change from baseline in gravimetrically measured sweat production. The secondary endpoints in both trials measured the proportion of patients who had at least a two-grade improvement from baseline, as measured by the Hyperhidrosis Disease Severity Scale (HDSS), and the proportion of patients with at least a 50% reduction from baseline in gravimetrically measured sweat production. Each endpoint was measured at the end of the four-week treatment period.
In the ATMOS-2 trial, DRM04 demonstrated statistically significant improvements for both coprimary endpoints and both secondary endpoints compared with vehicle. In the ATMOS-1 trial, DRM04 demonstrated statistically significant improvements for one of the coprimary endpoints and both secondary endpoints. For the second coprimary endpoint in the ATMOS-1 trial, when extreme outlier data from one analysis center were excluded in accordance with the prespecified statistical analysis plan submitted to the FDA, DRM04 demonstrated statistically significant results compared with vehicle.
Based on the findings from these studies, Dermira plans to submit a new drug application to the FDA for potential approval of DRM04 in the second half of 2017.
DRM04 is a topical anticholinergic product in clinical development for the treatment of primary axillary hyperhidrosis. The product is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat-gland activation.
Source: Dermira, Inc. (link is external); June 1, 2016.
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