Investigational topical promising underarm sweat treatment

June 10, 2016

Results indicate an investigational topical anticholinergic product in development for patients with primary axillary hyperhidrosis may offer patients an effective new treatment option if approved.

In June, Dermira announced safety and efficacy results of two phase 3 pivotal trials for DRM04, an investigational topical anticholinergic product in development for patients with primary axillary hyperhidrosis. Based on those results and subject to completion and results of a third trial, Dermira plans to submit a New Drug Application to the FDA in the second half of 2017.

“DRM04 is designed to reduce sweat production by blocking cholinergic receptors responsible for sweat gland activation,” Gene Bauer, M.D., chief medical officer and Dermira’s cofounder, tells Dermatology Times. “If approved, DRM04 would represent a non-invasive treatment option that can be self-administered once-daily by patients, differentiating it from some current treatments.”

In the ATMOS-1 trial, in which 229 patients were randomized to receive DRM04 and 115 to vehicle, 52.8% of DRM04-treated patients achieved at least a four-point improvement in sweating severity [measured by the Axillary Sweating Daily Diary (ASDD)]. That’s compared to 28.3% of patients in the vehicle group. DRM04 arm subjects experienced an average reduction in sweat production of 104.9 mg, versus 91.9 mg in vehicle-treated subjects.

As for secondary endpoints, in the active arm, 56.6% of patients achieved at least a two-grade improvement in the Hyperhidrosis Disease Severity Scale (HDSS) score, compared to 23.7% in the vehicle group. And 72.4% of applying DRM04 had at least a 50% reduction from baseline in gravimetrically-measured sweat production versus 53.2% in the vehicle arm.

In the ATMOS-2 trial, including 234 patients randomized to get DRM04 and 119 to vehicle, 66.1% of the active group achieved at least a four-point improvement in sweating severity, compared to 26.9% in the vehicle group. In the DRM04 arm, average reduction in sweat production was 110.3 mg, versus 92.2 mg among those applying the vehicle.

Nearly 62% in the active group achieved at least a two-grade improvement in HDSS score, compared to 27.8% in the vehicle group, and 77.3% of patients applying DRM04 had at least a 50% reduction in gravimetrically-measured sweat production, versus 53.3% of patients in the vehicle group.

“The results from these pivotal trials are very encouraging and demonstrate that DRM04 has the potential to be a new and differentiated treatment option for patients suffering from excessive underarm sweating,” says DRM04 clinical trial investigator David Pariser, M.D., professor of dermatology at Eastern Virginia Medical School, says in a Dermira press release. “Hyperhidrosis sufferers currently have limited treatment alternatives and, in my experience, are looking for new therapies that are effective and tolerable. Based on the efficacy and safety demonstrated in the Phase 3 trials, DRM04 may represent a convenient treatment option for patients living with this condition.”

Still pending is the completion of the phase 3 ARIDO trial, an open-label study looking at DRM04’s long-term safety.