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Dermira's QBREXZA (glycopyrronium) Cloth Is Now Available in Pharmacies Nationwide for the Treatment of Primary Axillary Hyperhidrosis
Globe Newswire 1-Oct-2018 7:30 AM
QBREXZA is now available in retail and community pharmacies across the United States
QBREXZA is the first and only FDA-approved, once-daily, topical prescription treatment indicated for people 9 years of age and older with primary axillary hyperhidrosis, also known as excessive underarm sweating
DermiraConnect is an access support program that provides affordability, fulfillment and adherence support
MENLO PARK, Calif., Oct. 01, 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, announced today that QBREXZA™ (glycopyrronium) cloth is now available for prescribing to treat primary axillary hyperhidrosis, commonly known as excessive underarm sweating. The new therapy is available in retail and community pharmacies nationwide. In June 2018, QBREXZA, a once-daily, prescription anticholinergic, 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 this chronic, medical skin condition.
The QBREXZA(TM) glycopyrronium cloth is now available in pharmacies nationwide for the treatment of primary axillary hyperhidrosis.
"People living with primary axillary hyperhidrosis often report feelings of isolation, and struggle in silence for years before finally speaking to a healthcare professional. In most instances, people are often too embarrassed to seek treatment, and when they do, they may not find solutions that effectively control their excessive underarm sweating," said Lisa J. Pieretti, Executive Director for the International Hyperhidrosis Society and a patient advocate for more than 15 years. "The availability of QBREXZA represents an FDA-approved, topical medicine for the millions of adults and children who may be looking for a new way to treat their excessive underarm sweating. It is my hope that many of these sufferers will finally get the sweat help they have been seeking much of their lives."
To provide seamless and affordable access to QBREXZA, Dermira recently announced the launch of DermiraConnect. The program is designed to offer financial assistance and other customized support services to eligible patients and healthcare professionals seeking to access QBREXZA.
To date, Dermira has secured coverage for approximately 53% of the total U.S. commercial lives, exceeding the Company's goal of securing more than 30% coverage by October 1, 2018 and 50% coverage by January 1, 2019.* In addition to Express Scripts, Inc. and OptumRx, several other payers have also agreed to provide access to QBREXZA through their national formularies beginning today.
"We are thrilled that QBREXZA is now available to dermatologists and patients as a new treatment option for primary axillary hyperhidrosis," said Tom Wiggans, chairman and chief executive officer at Dermira. "This condition can have a significant impact on the way people with this condition feel and the choices they make in their lives. We hope that patients treated with QBREXZA not only experience a reduction in sweat, but also a renewed confidence. No one, adult or child, should feel isolated or suffer in silence because of a treatable medical condition like primary axillary hyperhidrosis."
*Percentage calculated based on Dermira data on file.
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 DermiraConnect To ensure seamless, convenient and affordable access to our medicines, DermiraConnect is designed to offer financial assistance and other customized support services for eligible patients and healthcare professionals. For more information about DermiraConnect, visit www.dermiraconnect.com or call 1-877-DERMIRA.
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 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.
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 intended benefits of DermiraConnect of providing seamless and affordable access to QBREXZA; and the hope that patients treated with QBREXZA will not only experience a reduction in sweat, but also a renewed confidence. 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 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 potential 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 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 investor@dermira.com
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.
