MENLO PARK, Calif., Feb. 26, 2019 (GLOBE NEWSWIRE) -- Dermira, Inc. (DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people living with chronic skin conditions, today announced that new post-hoc analyses from its glycopyrronium tosylate (QBREXZA™ (glycopyrronium) cloth) clinical program will be presented in poster format at the 77th Annual Meeting of the American Academy of Dermatology (AAD) being held in Washington, D.C., March 1-5, 2019.
Poster presentations will highlight post-hoc data analyses from the Phase 3 clinical trials evaluating glycopyrronium tosylate in patients 9 years and older with primary axillary hyperhidrosis, commonly referred to as excessive underarm sweating. Two posters will feature new analyses from the ARIDO open-label, Phase 3 extension study and will focus on management of treatment-emergent adverse events, as well as efficacy for patients who were previously treated with vehicle and transitioned to glycopyrronium tosylate in ARIDO. A third poster will highlight data from the ATMOS-1 and ATMOS-2 Phase 3 trials evaluating glycopyrronium tosylate’s benefit in the treatment of primary axillary hyperhidrosis across a variety of sub-populations, including gender, race, and the presence or absence of other sites on the body affected by hyperhidrosis.
Primary axillary hyperhidrosis is a medical condition that results in sweating beyond what is needed for normal body temperature regulation. The condition affects more than 10 million people in the United States. Glycopyrronium tosylate, now QBREXZA™ (glycopyrronium) cloth, is a topical, once-daily anticholinergic cloth, designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation. QBREXZA was approved by the U.S. Food and Drug Administration in June 2018 to treat primary axillary hyperhidrosis in people 9 years of age and older.
“These data not only underscore glycopyrronium tosylate’s utility in helping to reduce a person’s excessive underarm sweat, but also highlight the potential benefit glycopyrronium tosylate could provide for patients currently living with this chronic skin condition longer-term,” said Eugene A. Bauer, M.D., chief medical officer at Dermira. “We are committed to understanding the full benefit of glycopyrronium tosylate and how it can have a positive impact on different populations of people living with primary axillary hyperhidrosis, a chronic medical condition affecting millions of people in the United States.”
Posters of Interest
Oral Poster Presentation
Friday, March 1, 2019 from 11:00-11:05 a.m. ET
Walter E. Washington Convention Center
Hall H, ePoster Presentation Center 1
Also available as an ePoster throughout the conference in Hall D
Poster 9906: An Evaluation of Anticholinergic Adverse Events with Long-Term Use of Topical Glycopyrronium Tosylate, a Treatment for Primary Axillary Hyperhidrosis
Available: Friday, March 1 through Sunday, March 3, 2019
9:00 a.m. – 5:00 p.m. ET
Hall D, Walter E. Washington Convention Center
Poster 8599: Glycopyrronium Cloth Improves Axillary Hyperhidrosis Across a Broad Spectrum of Patients: Post Hoc Analyses of the ATMOS-1 and ATMOS-2 Phase 3 Randomized Controlled Trials in Patient Subpopulations
Poster 9910: Long-Term Response of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis According to Double-Blind Treatment Group
All three posters are also available via the AAD mobile app starting March 1st at 7:00 AM EST.
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 million people.1 Of these, 65 percent, or nearly 10 million people, suffer from sweating localized to the underarms (axillary disease). Studies have demonstrated that excessive sweating often impedes normal daily activities and can also result in occupational, emotional, psychological, social and physical impairment.1,2
About QBREXZA™ (glycopyrronium) cloth
QBREXZA (pronounced kew brex’ zah) is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. QBREXZA is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation. For more information visit www.QBREXZA.com.
Important Safety Information
QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA.
WARNINGS AND PRECAUTIONS
Worsening of Urinary Retention: Use with caution in patients with a history or presence of documented urinary retention.
Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA.
Operating Machinery or an Automobile: Transient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
The most common adverse reactions seen in ≥2% of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat (2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions of erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
It is important for patients to understand how to correctly apply QBREXZA (see Patient Product Information). Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
Please see Full Prescribing Information.
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, develop and commercialize leading-edge medical dermatology products. The company’s approved treatment, QBREXZA™ (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages 9 and older) with primary axillary hyperhidrosis (excessive underarm sweating). Dermira is also evaluating lebrikizumab in a Phase 2b clinical trial for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and has early-stage research programs in other areas of dermatology. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow Dermira on Twitter, LinkedIn and Instagram.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com), LinkedIn page (https://www.linkedin.com/company/dermira-inc-), corporate Instagram account (https://www.instagram.com/dermira_inc/) and corporate Twitter account (@DermiraInc) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website, LinkedIn page, Instagram and Twitter accounts in addition to following its SEC filings, news releases, public conference calls and webcasts.
The information in this news 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 news release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to: Dermira’s goal of bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; and the potential longer-term benefit glycopyrronium tosylate could provide for patients currently living with 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 Dermira’s dependence on third-party clinical research organizations, manufacturers, suppliers and distributors; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; market acceptance of Dermira’s current and future products; the impact of competitive products and therapies; Dermira’s ability to manage the growth and complexity of its organization; Dermira’s ability to maintain, protect and enhance its intellectual property; and Dermira’s ability to continue to stay in compliance with its material contractual obligations, 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 news 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.
Vice President, Corporate Communications
Director, Corporate Communications
Ian Clements, Ph.D.
Vice President, Investor Relations
- Doolittle et. al., Hyperhidrosis: An Update on Prevalence and Severity in the United States. Arch Dermatol Res. 308:743-749, 2016.
- Kamudoni, et al., The impact of hyperhidrosis on patients’ daily life and quality of life: a qualitative investigation. Health and Quality of Life Outcomes, 15(1). 2017.