Proprietary Axillary Sweating Daily Diary patient-reported outcome instrument developed with feedback from FDA
MENLO PARK, Calif., March 21, 2017 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today presented new information about the Axillary Sweating Daily Diary (ASDD), a proprietary patient-reported outcome (PRO) instrument designed to measure the sweating severity of axillary hyperhidrosis and its impact on daily activities and bothersomeness for patients. The presentation took place at the 13th Annual Maui Derm for Dermatologists 2017 meeting in Maui, Hawaii.
Hyperhidrosis is a condition of sweating beyond what is physiologically required for normal thermal regulation and affects an estimated 4.8% of the U.S. population, or approximately 15.3 million people. According to a published study, 65% of hyperhidrosis sufferers in the United States have axillary hyperhidrosis, and approximately half of those axillary hyperhidrosis sufferers, or 5.2 million Americans, have severe disease that is barely tolerable and frequently interferes or is intolerable and always interferes with daily activities.1 Other studies have further demonstrated that excessive sweating often impedes normal daily activities and can also result in occupational, emotional, psychological, social and physical impairment. 2,3
“Based on recent estimates, hyperhidrosis appears to be one of the more prevalent skin conditions in the general population,” said Eugene A. Bauer, M.D., chief medical officer of Dermira and a dermatologist. “We believe that the ASDD PRO represents an important new tool to enable clinicians to evaluate the impact a treatment for excessive sweating is having on the patient’s condition.”
Despite the high prevalence and impact of hyperhidrosis, few disease-specific measures which accurately assess patient outcomes exist. While the Hyperhidrosis Disease Severity Scale (HDSS) has been widely used in hyperhidrosis clinical studies for more than a decade, the U.S. Food and Drug Administration (FDA) determined that it does not conform to the agency’s standards for PRO measures that can be used to support a current product approval and labeling. 4,5
Dermira developed the ASDD instrument in accordance with the 2009 FDA guidance document for PRO instruments. The ASDD was 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 ASDD PRO instrument was first evaluated by Dermira during a Phase 2b clinical trial assessing the safety and efficacy of glycopyrronium tosylate (formerly DRM04) in 102 patients with primary axillary hyperhidrosis (excessive underarm sweating). The psychometric properties of ASDD Item 2 were validated using data generated from this Phase 2b trial and 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.
As previously reported, in two Phase 3 trials, the glycopyrronium tosylate-treated patients experienced an improvement in their sweating severity compared to vehicle, as measured by ASDD, beginning at week 1 in ATMOS-1 (22.9% vs. 5.3%) and ATMOS-2 (29.0% vs. 4.2%), that continued through the completion of the 4-week treatment period.
About Glycopyrronium Tosylate
Glycopyrronium tosylate is formulated as a topical, once-daily anticholinergic agent that is currently in clinical development for the treatment of primary axillary hyperhidrosis. Glycopyrronium tosylate is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation. Dermira intends to submit a New Drug Application (NDA) to the FDA for glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in the second half of 2017, subject to the completion of registration-enabling activities.
- Doolittle et. al., Hyperhidrosis: An Update on Prevalence and Severity in the United States. Arch Dermatol Res. 308:743-749, 2016.
- Bahar et. al., The prevalence of anxiety and depression in patients with or without hyperhidrosis (HH). J Am Acad Dermatol. 75(6): 1126-1133, 2016.
- Augustin et. al., Prevalence and disease burden of hyperhidrosis in the adult population. Dermatology. 227: 10-13, 2013.
- Kowalski et. al., Validity and Reliability of the Hyperhidrosis Disease Severity Scale (HDSS). J Am Acad Dermatol. 50(3): P51, 2004.
- Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA, 2009.
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s product pipeline includes three Phase 3 product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil (formerly DRM01), in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com.
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The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to the ASDD PRO representing an important new tool for clinicians to evaluate the impact a treatment for excessive sweating is having on a patient’s daily activities and bothersomeness; and the timing and submission of an NDA to the FDA for glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcome of Dermira’s clinical trials; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; Dermira’s ability to obtain regulatory approval for its product candidates; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
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Robert H. Uhl