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Dermira Initiates Proof-of-Concept Study to Evaluate QBREXZA (glycopyrronium) Cloth in Patients with Primary Palmar Hyperhidrosis
Globe Newswire 22-Feb-2019 8:02 AM
- Study will assess the impact of QBREXZA treatment on sweat severity in patients with primary palmar hyperhidrosis - Results will inform potential development plans for QBREXZA in primary palmar hyperhidrosis - Findings from the study are expected in the second half of 2019
MENLO PARK, Calif., Feb. 22, 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 people living with chronic skin conditions, announced today the initiation of a proof-of-concept study that will evaluate the efficacy and safety of QBREXZA™ (glycopyrronium) cloth in people living with primary palmar hyperhidrosis (excessive sweating of the hands).
QBREXZA is a once-daily, prescription anticholinergic that was approved by the U.S. Food and Drug Administration (FDA) to treat adult and pediatric patients 9 years of age and older living with primary axillary hyperhidrosis, a medical condition commonly referred to as excessive underarm sweating.
"People suffering from palmar hyperhidrosis frequently cite it as debilitating, difficult to effectively manage and a major influence on their life choices," said Lisa J. Pieretti, Executive Director for the International Hyperhidrosis Society and a patient advocate for more than 15 years. "New treatment alternatives are needed to help manage this condition, which can have a significant negative impact on everything from a child's time on a playground to an individual's first job interview."
Hyperhidrosis is a condition that often affects multiple parts of a person's body. In the Phase 3 clinical trials that led to the approval of QBREXZA for axillary hyperhidrosis, 34% of the people participating also reported suffering from palmar hyperhidrosis. QBREXZA is not currently FDA-approved to treat primary palmar hyperhidrosis, a condition that affects approximately six million people in the United States.1
Following the approval of QBREXZA in 2018, Dermira initiated preclinical research studies designed to understand how glycopyrronium tosylate could benefit other areas of the body beyond the axillae (underarms). Specifically, these studies tested whether glycopyrronium tosylate penetration into human skin is impacted by occlusion (covering the skin), washing the skin and skin thickness. The findings from these studies helped to inform the proof-of-concept study design.
"We have long recognized that, similar to axillary hyperhidrosis, palmar hyperhidrosis is highly prevalent and can adversely affect the emotional and social well-being of people living with this condition," said Luis Peña, chief development officer of Dermira. "Given our commitment to the hyperhidrosis patient community, the goal of the proof-of-concept study is to determine if the current formulation of QBREXZA is effective in reducing sweat production on a person's hands, which would allow us to determine if there is a viable development and regulatory path for the treatment of primary palmar hyperhidrosis."
The randomized, vehicle-controlled, parallel group proof-of-concept study is designed to determine an appropriate dosing regimen for QBREXZA to treat primary palmar hyperhidrosis. The study will enroll approximately 60 patients ages 9 years and older at eight sites in the United States. Findings from the study are expected in the second half of 2019 and will inform next steps for a potential primary palmar hyperhidrosis development program.
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), while 40 percent suffer from sweating on their hands. 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
CONTRAINDICATIONS 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.
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 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.
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 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.
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 successful completion of, and timing expectations for the receipt and announcement of topline data from, the proof-of-concept study to evaluate the efficacy and safety of QBREXZA™ (glycopyrronium) cloth in people living with primary palmar hyperhidrosis; the goal of the proof-of-concept study to determine if the current formulation of QBREXZA is effective in reducing sweat production on a person's hands; the design and description of the proof-of-concept study; and potential development plans for QBREXZA in primary palmar 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; the design, implementation and outcomes of Dermira's clinical trials; the outcomes of future meetings with regulatory agencies; 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.
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.
