DRM04: Phase IIb data

The double-blind, North American Phase IIb DRM04-HH02 trial in 105 patients with severe, primary axillary hyperhidrosis for >=6 months showed that a greater proportion of patients receiving 1 of 2 concentrations of once-daily topical DRM04 achieved a >=2 grade improvement in HDSS from baseline to week 4 vs. vehicle-treated controls (40.9-50% vs. 27.3%). DRM04 also led to a greater reduction in average sweat production from baseline to week 4 vs. vehicle (67.7-79.8% vs. 48.7%). Dermira also said DRM04 led to greater improvements in disease severity as measured by ASDD scores vs. vehicle. The company said the trial was not powered for significance. DRM04 was well tolerated with no treatment-related serious adverse events reported. The most common adverse events reported were dry mouth, application-site pain and headache. ...