- 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
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 HyperhidrosisHyperhidrosis 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)
clothQBREXZA (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.
Please see Full Prescribing Information.
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.
Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216erica.jefferson@dermira.com
Erin MurphyDirector, Corporate Communications650-422-7746
erin.murphy@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@dermira.com
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