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Dermira Presents New Data from its Phase 3 Clinical Program Evaluating Glycopyrronium Tosylate (QBREXZA (glycopyrronium) cloth) in Patients with Primary Axillary Hyperhidrosis
Globe Newswire 1-Mar-2019 8:01 AM
Three poster presentations from Phase 3 glycopyrronium tosylate clinical program address clinically relevant questions impacting people living with primary axillary hyperhidrosis
New analysis from ATMOS-1 and ATMOS-2 Phase 3 studies illustrates efficacy across broad range of patient populations
Two additional analyses from ARIDO open-label extension study describe long-term safety and efficacy for up to 44 weeks of treatment
WASHINGTON, March 01, 2019 (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 post-hoc analyses from its glycopyrronium tosylate (now QBREXZA™ (glycopyrronium) cloth) Phase 3 clinical program at the Annual Meeting of the American Academy of Dermatology (AAD) in Washington, D.C. The poster presentations are now live in Hall D of the Walter E. Washington Convention Center.
"The data presented this week at AAD 2019 highlight the utility of glycopyrronium tosylate across multiple patient populations and further support its long-term efficacy and safety, as well as optimal management of treatment-emergent adverse events," said David Pariser, M.D., professor at Eastern Virginia Medical School, Department of Dermatology. "This information will help optimize the care provided to people living with primary axillary hyperhidrosis."
The glycopyrronium tosylate Phase 3 clinical program included two identical double-blind, vehicle-controlled, 4-week trials that enrolled patients 9 years and older with primary axillary hyperhidrosis. Patients were randomized to receive glycopyrronium tosylate or vehicle applied topically once daily. Those who completed these ATMOS-1 and ATMOS-2 trials were provided the opportunity to enter ARIDO, an open-label study designed to assess long-term safety and efficacy.
The new presentations from the ATMOS-1 and ATMOS-2 trial results highlight efficacy data for glycopyrronium tosylate versus vehicle across a broad range of patient populations. Additional analyses of the ARIDO open-label extension study present long-term efficacy and safety data through week 44 in patients previously treated with either glycopyrronium tosylate or vehicle in the ATMOS-1 and ATMOS-2 trials. The final presentation shows that during the open-label study, treatment-emergent adverse events of special interest decreased over time and the majority of anticholinergic adverse events could be managed without treatment discontinuation.
"Our goal is to understand hyperhidrosis as a medical condition, as we consider how we can bring the best possible treatment to patients now and in the future," said Eugene A. Bauer, M.D., chief medical officer at Dermira and a dermatologist. "The data presented this week underscore our confidence in glycopyrronium tosylate's potential to provide long-term benefit to a broad spectrum of adults and younger people with excessive underarm sweating."
Data presented in poster sessions this week include:
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 ePoster presentation: March 1-3, Hall D Authors: D. Glaser, L. Green, J. Drew, R. Gopalan, M. Zastrow, D.M. Pariser
Week 4 data showed a reduction in sweating severity (ASDD Item 2*) and sweat production and improvement in quality of life measures (HDSS**and DQLI***), compared with vehicle. This outcome was independent of patient characteristics, including hyperhidrosis focality, prior hyperhidrosis treatment, gender, age, and race.
Overall, glycopyrronium tosylate was well tolerated across patient subgroups, and most adverse events were mild to moderate in severity and infrequently led to discontinuation.
Poster 9906: An Evaluation of Anticholinergic Adverse Events with Long-Term Use of Topical Glycopyrronium Tosylate, a Treatment for Primary Axillary Hyperhidrosis Oral poster presentation: March 1, 11:00-11:05am ET, Hall H, ePoster Presentation Center Authors: D.M. Pariser, J. Drew, R. Gopalan, M. Zastrow, A. Hebert
Treatment-emergent adverse events (TEAEs), including those associated with anticholinergic activity, were mostly mild/moderate, decreased in incidence over time, and infrequently led to discontinuation over a 44-week period.
Anticholinergic side effects were managed via dose interruption, dosing frequency alteration, drug discontinuation and without changes to dosing.
Poster 9910: Long-Term Response of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis According to Double-Blind Treatment Group ePoster presentation: March 1-3, Hall D Authors: E.L. Lain, D. Glaser, R. Gopalan, V. Yan, J. Drew, D.M. Pariser
The poster shows improvement in quality of life assessments in patients who entered the ARIDO open-label extension trial irrespective of randomized treatment in the double-blind trials, as well as safety data in patients with primary axillary hyperhidrosis over a maximum of 48 weeks.
*ASDD Item 2: Axillary Sweating Daily Diary, Dermira's proprietary patient-reported outcomes tool **HDSS: Hyperhidrosis Disease Severity Scale ***DLQI: Dermatology Quality of Life Index
About Hyperhidrosis 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
IMPORTANT SAFETY INFORMATION
Contraindications: QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren's syndrome).
WARNINGS AND PRECAUTIONS
Worsening of Urinary Retention: QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
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. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
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.
ADVERSE REACTIONS
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, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
DRUG INTERACTIONS
Anticholinergics: Coadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZA
Instruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.
About Dermira 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 nine 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 and development 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.
Forward-Looking Statements 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; the potential for glycopyrronium tosylate to treat multiple patient populations now and in the future and to be an effective longer-term treatment option. 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; the design, implementation and outcomes of Dermira's clinical trials; the outcomes of future meetings with regulatory agencies; Dermira's ability to develop and maintain collaborations and license products and intellectual property; Dermira's ability to attract and retain key employees; Dermira's ability to obtain necessary additional capital; market acceptance of Dermira's current and potential 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.
Investors: Ian Clements, Ph.D. Vice President, Investor Relations 650.422.7753 ian.clements@dermira.com
References:
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.
