Dermira reports Phase III hyperhidrosis data

Dermira Inc. (NASDAQ:DERM) said DRM04 met both co-primary endpoints in the Phase III ATMOS-2 trial and one of two co-primary endpoints in the Phase III ATMOS-1 study to treat primary axillary hyperhidrosis. The company hopes to submit an NDA to FDA in 2H17.

In ATMOS-1's intent-to-treat (ITT) population, significantly more patients receiving DRM04 had Axillary Sweating Daily Diary (ASDD) scores that improved by at least four points vs. patients receiving vehicle (p<0.001), meeting one co-primary endpoint. DRM did not significantly reduce average sweat production from baseline vs. vehicle (p=0.065), another co-primary endpoint. Dermira said that when data from one clinical site were excluded according to a pre-specified analysis plan, DRM04 met the latter endpoint (p<0.001). ...