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Dermira Presents New Pediatric Efficacy and Safety Data for Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis at the European Academy of Dermatology and Venereology Congress
- Primary axillary hyperhidrosis is a medical condition that can occur in the pediatric population and is largely undertreated and under-diagnosed
- Post-hoc analysis of ARIDO long-term safety study demonstrated reduced sweat production, and improved disease severity and quality of life, relative to vehicle in pediatric patients 9 years and older
MENLO PARK, Calif., Sept. 13, 2018 (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 people living with chronic skin conditions, today presented data from a post-hoc analysis of the Phase 3 open-label ARIDO study which evaluated the long-term safety of glycopyrronium tosylate in patients with primary axillary hyperhidrosis. The data showed the response of pediatric patients (ages 9 to 16) compared to older patients (ages 17 years and older) with primary axillary hyperhidrosis who received treatment with glycopyrronium tosylate (now QBREXZA™ (glycopyrronium) cloth). Compared to adult patients, pediatric patients receiving glycopyrronium tosylate experienced similar rates of improved disease severity and decreased sweat production, and reported improved quality of life.
These data were presented in an oral presentation by Dr. Lawrence Green today during the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.
Primary axillary hyperhidrosis, commonly known as excessive underarm sweating, is a chronic medical skin condition that results in sweating beyond what is needed for normal body temperature regulation. The exact cause is unknown. It affects nearly 10 million people in the United States, and both men and women similarly.
Glycopyrronium tosylate is a once-daily, topical anticholinergic cloth designed to block sweat production by inhibiting the receptors responsible for sweat gland activation.
“Primary axillary hyperhidrosis affects people of all ages, yet there are few treatment options to address this condition,” said Lawrence J. Green, M.D., associate clinical professor, Department of Dermatology at George Washington University School of Medicine. “The findings observed in the Phase 3 glycopyrronium tosylate studies collectively demonstrate comparable rates of efficacy and safety following treatment with the therapy in both adults and children, giving us greater confidence that the therapy may provide an effective treatment option for young sufferers of this often embarrassing medical condition.”
Results from an analysis of pediatric patients from the Phase 3 ATMOS-1 and ATMOS-2 clinical trials were initially presented earlier this year at the 76th Annual Meeting of the American Academy of Dermatology. The new post-hoc analysis presented today from the Phase 3 ARIDO study was designed to assess the long-term safety of glycopyrronium tosylate in pediatric and adult patients (ages 9 years and older) who participated in the ATMOS-1 and ATMOS-2 studies, respectively. Pooled data evaluated pediatric patients (ages 9 to 16) versus adult patients (ages 17 and older). Patients who participated in ARIDO received up to an additional 44 weeks of treatment with glycopyrronium tosylate. Of the 44 pediatric patients randomized in ATMOS-1 and ATMOS-2, 43 completed either trial and 38 entered ARIDO.
Key findings from the post-hoc analysis of ARIDO include:
- The median absolute decrease in sweat production at 44 weeks of treatment for pediatric vs. adult patients was -50.3 mg (n=30) vs. -75.1 mg (n=400).
- The proportion of patients achieving a Hyperhidrosis Disease Severity Scale (HDSS) response (≥2 grade improvement from baseline) was 56.7% for pediatric patients (n=30) vs. 63.6% for adult patients (n=407).
- Pediatric patients experienced a mean decrease from baseline in the Children’s Dermatology Quality of Life Index of -6.2 (n=26) while adult patients experienced a mean decrease from baseline in the Dermatology Life Quality Index of -8.7 (n=406).
- The rates of treatment-emergent adverse events reported for pediatric vs. adult patients up to 44 weeks were 57.9% (n=22) vs. 60.0% (n=512). Most were related to anticholinergic activity and were mild, transient and infrequently led to discontinuation of treatment.
“Primary axillary hyperhidrosis is a medical condition that can present during adolescence and if left untreated can have a profoundly negative effect on the formative years of a child,” said Eugene Bauer, M.D., chief medical officer of Dermira and a dermatologist. “From the beginning, our goal has been to develop a meaningful treatment option that benefits both adults and children. The results of the ATMOS-1, ATMOS-2 and ARIDO studies collectively underscore the potential benefit glycopyrronium tosylate could provide for young patients currently living with this chronic skin condition.”
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.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
Glycopyrronium tosylate, commercially known as 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.
QBREXZA was approved in June 2018 for the treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years and older.
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 and develop leading-edge medical dermatology programs. 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.
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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 to develop a meaningful treatment option that benefits both adults and children suffering from primary axillary hyperhidrosis; the potential benefits QBREXZA could provide for young patients currently living with primary axillary hyperhidrosis; and the belief that QBREXZA may provide an effective treatment option for young sufferers 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 Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; market acceptance of Dermira’s potential products; the impact of competitive products and therapies, including generics and biosimilars; 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 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 undertake 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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