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 SubpopulationsePoster 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
HyperhidrosisOral 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 DAuthors: 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 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). 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
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.
Please see Full Prescribing Information.
About DermiraDermira 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.
Dermira Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650.421.7216erica.jefferson@dermira.com
Erin MurphyDirector, Corporate
Communications650.422.7746erin.murphy@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650.422.7753ian.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.
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