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.
To further assess the impact of treatment with 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) 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 and drafted based on clinical expertise, literature review and feedback from the FDA. The ASDD was further refined based on qualitative interviews with adults and children (21 adults and 8 children). A child-specific version was developed (ASDD-C) for assessment of sweating severity in patients 16 years of age and younger.
The ASDD consists of four distinct items that ask patients various questions about their excessive sweating. Item 1 is a gating question that establishes a patient’s baseline sweating during a 24-hour period, Item 2 addresses sweating severity and Items 3 and 4 measure the impact of the excessive sweating on a patient’s daily activities and bothersomeness. Two additional sections of the instrument assess the weekly impact of the patient’s sweating (Item 5) and the overall impact of the patient’s sweating following treatment in a clinical study (Item 6). The psychometric properties of ASDD Item 2 were validated using data generated from the glycopyrronium tosylate Phase 2b trial, which allowed this item to be used specifically as a key clinical endpoint to evaluate the effectiveness of treatment with glycopyrronium tosylate in Phase 3 studies.