Glycopyrronium Tosylate (formerly DRM04)

Re-designing treatment for primary axillary hyperhidrosis.

Glycopyrronium tosylate is an anticholinergic agent formulation for once-daily, topical administration that has been evaluated in Phase 3 clinical testing for the treatment of primary axillary hyperhidrosis (excessive underarm sweating).

This therapy is designed to block sweat production following topical application by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.

Safety and efficacy evaluated in Phase 3 clinical trials.

Dermira evaluated the safety and efficacy of topically applied glycopyrronium tosylate in patients with primary axillary hyperhidrosis in a Phase 3 clinical program. Topline results from the randomized, double-blind, vehicle-controlled, multi-center ATMOS-1 and ATMOS-2 pivotal studies have been reported.

As part of measuring the efficacy of glycopyrronium tosylate, Dermira developed a new patient-reported outcome (PRO) instrument to measure sweating severity. This measurement of sweating severity was a co-primary efficacy endpoint in the Phase 3 ATMOS-1 and ATMOS-2 studies. This new PRO is a proprietary questionnaire called the Axillary Sweating Daily Diary (ASDD) PRO and assesses not only sweating severity but the impact this sweating has on a person’s daily activities. The ASDD PRO was developed in consideration of the 2009 U.S. Food and Drug Administration (FDA) guidance document for PRO instruments.

Developed with patients’ needs in mind.

Patients with primary axillary hyperhidrosis have limited treatment options and are seeking new, safe and effective therapies.

Glycopyrronium tosylate was developed to treat primary axillary hyperhidrosis with the needs of the patient in mind. It represents a potential non-invasive topical treatment option that can be self-administered. Based on Phase 3 clinical trial results to date, glycopyrronium tosylate, if approved, could represent a meaningful new treatment option for patients living with hyperhidrosis.

Dermira plans to submit a New Drug Application (NDA) for glycopyrronium tosylate to the U.S. FDA in the second half of 2017, subject to the completion of registration-enabling activities.