Dermira, a biopharmaceutical company, recently announced the topline results from two phase 3 pivotal trials for a topical, anticholinergic product in development to treat primary axillary hyperhidrosis.
DRM04 is designed to block sweat production by inhibiting the interaction between the cholinergic receptors responsible for sweat gland activation and acetylcholine, according to a company press release.
“These results from the ATMOS-1 and ATMOS-2 trials bring us a step closer to offering DRM04 as a once-daily, topical treatment for the millions of people who suffer from primary axillary hyperhidrosis, an undertreated skin condition,” Thomas G. Wiggans, MBA, chairman and CEO of Dermira, said in the release.
The product demonstrated statistically significant improvements for both the co-primary endpoints and secondary endpoints — sweat severity and production — in the ATMOS-2 trial for the treatment of primary axillary hyperhidrosis compared with a vehicle, according to the release.
In the ATMOS-1 trial, DRM04 showed statistically significant improvements for one of the co-primary endpoints and for both secondary endpoints. For the second co-primary endpoint, when extreme outlier data from one analysis center were excluded in accordance with the pre-specified statistical analysis plan submitted to the FDA, it demonstrated statistically significant results compared with a vehicle.
Dry mouth and application site pain were the most commonly reported adverse events in both trials.
The results were based on the overall dataset from the intent-to-treat population, the release said.
Based on these results, Dermira announced it will submit a new drug application to the FDA for approval of DRM04, with a submission target for the second half of 2017.