DRM04 is a small-molecule anticholinergic product for topical application currently in clinical development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating).
Sweat is produced by glands in the skin and sweat gland activity is controlled by the nervous system. The nervous system transmits signals to the sweat glands through a molecule called acetylcholine, which is known as a neurotransmitter.
DRM04 is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation. The concept of inhibiting sweat production by blocking acetylcholine neurotransmission has been clinically validated in studies of Botox and oral anticholinergics for the treatment of hyperhidrosis. We believe that local, topical administration of DRM04 may offer advantages over oral administration of an anticholinergic by limiting uptake into the systemic circulation and thereby reducing the likelihood and severity of systemic side effects.
In June 2016, we announced topline results from our Phase 3 ATMOS-1 and ATMOS-2 pivotal clinical trials evaluating DRM04 as a potential treatment for patients with primary axillary hyperhidrosis. Based on the results, we plan to submit a New Drug Application (NDA) to the FDA for potential approval of DRM04. The NDA submission is targeted for the second half of 2017, subject to the completion of the open-label Phase 3 ARIDO trial, which is assessing the long-term safety of DRM04, as well as other registration-enabling activities and a pre-NDA meeting with the FDA.
If approved, we believe that DRM04 may offer advantages over currently approved alternatives by providing a self-administered, non-invasive, once-daily treatment option.