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 the U.S. Food and
Drug Administration (FDA) has approved Qbrexza™ (glycopyrronium)
cloth, an anticholinergic indicated for the topical treatment of
primary axillary hyperhidrosis in adult and pediatric patients 9
years of age and older.
Primary axillary hyperhidrosis, also commonly known as excessive
underarm sweating, is a chronic medical skin condition that results
in sweating beyond what is needed for normal body temperature
regulation. The exact cause is unknown, but it affects nearly 10
million people in the United States, with both men and women having
similar prevalence. Qbrexza (pronounced kew brex’ zah) is applied
directly to the skin and is designed to block sweat production by
inhibiting sweat gland activation.
“For years, dermatologists have been telling us of the need for
new treatment options that address primary axillary hyperhidrosis
given the stigma and burden associated with this condition,” said
Tom Wiggans, chairman and chief executive officer at Dermira. “From
the start, our goal was to develop an approach that went beyond
masking a person’s excessive underarm sweating and instead focused
on treating the condition in a clinically meaningful way. We
partnered with dermatologists and the FDA during the development
stage and listened to the people who have been living with this
condition to understand how they would define a meaningful benefit.
It is our hope that Qbrexza will not only provide the clinical
benefit these sufferers have been seeking, but help to reduce the
overall burden on their lives.”
The approval is based on results from two Phase 3 clinical
trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and
safety of Qbrexza in patients with primary axillary hyperhidrosis.
Both trials assessed the absolute change from baseline in sweat
production (the weight or amount of sweat a patient produced)
following treatment with Qbrexza and the proportion of patients who
achieved at least a four-point improvement from baseline in their
sweating severity, as measured by the Axillary Sweating Daily Diary
(ASDD), Dermira’s proprietary patient-reported outcome (PRO)
instrument. The PRO was developed in consultation with the FDA and
in accordance with the agency’s 2009 guidance on PRO
instruments.
“Primary axillary hyperhidrosis is a condition that has
negatively impacted many of my patients for most of their lives,”
said Dee Anna Glaser, M.D., professor and interim chair, Department
of Dermatology at Saint Louis University School of Medicine and a
renowned hyperhidrosis expert. “I look forward to Qbrexza’s
potential to be a meaningful treatment option that will not only
reduce a person’s sweat, but will reduce the overall impact this
condition has on their daily life.”
The most common side effects observed following topical
application of Qbrexza to the underarms were dry mouth, dilated
pupil (mydriasis), sore throat (oropharyngeal pain), headache,
urinary hesitation, blurred vision, dry nose, dry throat, dry eye,
dry skin and constipation. The most common local skin reactions
were erythema, burning/stinging and pruritus.
Qbrexza is expected to be available nationwide in pharmacies
beginning in October 2018. For more information, visit
www.qbrexza.com.
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 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 (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 and Patient Product
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 and develop leading-edge medical
dermatology programs. The company’s approved treatment, Qbrexza™
(glycopyrronium) cloth, is an anticholinergic indicated for the
topical treatment of primary axillary hyperhidrosis in adult and
pediatric patients 9 years of age and older. Primary axillary
hyperhidrosis is excessive underarm sweating with no known cause
and beyond what is needed for normal body temperature regulation.
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 and LinkedIn.
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-) 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 and Twitter account 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
hope that Qbrexza will not only provide the clinical benefit to
sufferers of primary axillary hyperhidrosis, but help to reduce the
overall daily burden this condition has had on their lives;
Qbrexza’s potential to be a meaningful treatment option that will
not only reduce a person’s sweat, but will reduce the overall
impact of primary axillary hyperhidrosis on their lives; the
commercial launch of Qbrexza; and the date by which Qbrexza will be
commercially available nationwide. 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 and
suppliers; Dermira’s ability to attract and retain key employees;
Dermira’s ability to obtain necessary additional capital; market
acceptance of Dermira’s potential products; Dermira’s ability to
develop and maintain collaborations and license products and
intellectual property; the impact of competitive products and
therapies, including generics and biosimilars; Dermira’s ability to
manage the growth and complexity of its organization; Dermira’s
ability to maintain, protect and enhance its intellectual property;
the design, implementation and outcomes of Dermira’s clinical
trials; the outcomes of Dermira’s future meetings with regulatory
agencies; 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
undertake 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.
Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216erica.jefferson@dermira.com
Erin MurphyAssociate Director, Corporate
Communications650-422-7746erin.murphy@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@dermira.com
Robert H. Uhl Westwicke PartnersManaging
Director858-356-5932robert.uhl@westwicke.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.
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