DUBLIN, July 6, 2020
/PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today
announced that it received U.S. Food and Drug Administration (FDA)
approval of Qwo™ (collagenase clostridium histolyticum-aaes) for
the treatment of moderate to severe cellulite in the buttocks of
adult women. QWO is the first FDA-approved injectable
treatment for cellulite.
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"Today's FDA approval of QWO is a key achievement in the
continued execution of Endo's long-term strategy, especially as it
relates to building our portfolio and capabilities for the future,"
said Blaise Coleman, President and
Chief Executive Officer of Endo. "As Endo embarks on an exciting
new journey into medical aesthetics, we look forward to bringing
this innovative treatment to market through our Endo Aesthetics
organization."
While cellulite is known to be a multifactorial condition, a
primary contributing factor is the fibrous connective tissue,
called the "fibrous septae," which connect the skin perpendicularly
to the fascia below.2,3 These fibrous septae tether the
skin, drawing it downward and leading to a mattress-like
appearance, commonly referred to as "dimpling."4,5
When injected into the treatment area, QWO is thought to
release the fibrous septae enzymatically by specifically targeting
Types 1 and 3 collagen, which may result in smoothing of the skin
and an improved appearance of cellulite.1
"Endo recognized a significant unmet need for an effective and
non-invasive injectable treatment for cellulite, which led us to
conduct the largest clinical trials in the history of cellulite
investigation in the United
States," said Matthew Davis,
M.D., R.Ph., Senior Vice President and Chief Medical Officer of
Endo. "Supported by rigorous research, testing and development
processes, we are proud to have received FDA approval of the first
injectable treatment for cellulite in the buttocks and we look
forward to delivering QWO to the aesthetics community and their
adult female patients."
Side effects of QWO included injection site bruising, pain,
areas of hardness and itching in the treatment area. Please
see Important Safety Information below for more details.
"QWO could be a game-changer for many women with
cellulite," said Anne Chapas,
M.D., a board-certified dermatologist at Union Square
Laser Dermatology in New York
City. "I am thrilled there will now be an FDA-approved
injectable treatment option proven to address a root cause of
cellulite. What is exciting about QWO is that it is
a cutting-edge cellulite treatment, without the cutting."
QWO is expected to be available throughout the United States at aesthetic healthcare
practitioner's offices starting in Spring 2021. Physicians and
consumers are encouraged to visit www.QWO.com and sign up for
updates on product availability.
WHAT IS QWO™?
QWO is a prescription medicine used to treat moderate to severe
cellulite in the buttocks of adult women.
IMPORTANT SAFETY INFORMATION
Do not receive QWO if you: are allergic to collagenase or
to any of the ingredients in QWO, or have an active infection at
the treatment area.
QWO may cause serious side effects, including:
- Allergic (hypersensitivity) reactions, including
anaphylaxis. Call your healthcare provider right away if you
have hives, trouble breathing, low blood pressure, swollen face,
chest pain, dizziness or fainting after receiving QWO;
- Injection site bruising
Before receiving QWO, tell your healthcare provider if
you:
- have a bleeding problem
- are pregnant or may become pregnant, nursing or plan to nurse.
You and your healthcare provider should decide if you will receive
QWO or breastfeed.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins and herbal supplements. Especially tell your healthcare
provider if you take a medicine that prevents the clotting of
your blood (antiplatelet or anticoagulant).
The most common side effects of
QWO include: injection site bruising, pain,
areas of hardness, itching, redness, discoloration, swelling and
warmth in the treatment area.
These are not all the possible side effects of QWO. Call your
healthcare provider for medical advice about side effects. You are
encouraged to report side effects of prescription drugs to the FDA
at www.fda.gov/medwatch or 1-800-FDA-1088.
Click for Full Prescribing
Information, including Patient Information for
QWO.
About Cellulite
Cellulite is a localized alteration in
the contour of the skin that has been reported in over 90 percent
of post-pubertal females and affects women of all races and
ethnicities.6,7 The presence of cellulite is
associated with changes in dermal thickness and in the fat cells
and connective tissue below the skin.8 A primary factor
in the cause of the condition is the collagen containing septae
which attach the skin to the underlying fascia
layers.2,3 The septae tether the skin which, with
additional contributing protrusions of subcutaneous fat, causes the
surface dimpling characteristic of cellulite.4,5 These
fibrous septae are oriented differently with varying thickness in
females than in males, which informs our understanding of cellulite
as a gender-related condition.9 Cellulite clinically
presents on the buttocks, thighs, lower abdomen and
arms.6
It is known that cellulite is different from generalized
obesity.10 In generalized obesity, adipocytes undergo
hypertrophy and hyperplasia that is not limited to the pelvis,
thighs, and abdomen.7 In areas of cellulite,
characteristic large, metabolically stable adipocytes have
physiologic and biochemical properties that differ from adipose
tissue located elsewhere.11 An anatomical study in
2019 found that women have increased fat lobule height compared
with men, which may also contribute to the mattress-like appearance
seen as a result of the tension of the fibrous
septae.9,11 Weight gain can make cellulite more
noticeable, but cellulite may be present even in thin
subjects.10
About Endo Aesthetics™ LLC
Endo Aesthetics is
embarking on a mission devoted to pushing the boundaries of
aesthetic artistry. Driven by world-class research and development,
Endo Aesthetics is advancing solutions to address unmet needs
beginning with the first FDA-approved injectable treatment for
cellulite in the buttocks. Headquartered in Malvern, PA, Endo Aesthetics is an affiliate
of Endo International plc (NASDAQ: ENDP). Learn more at
www.endoaesthetics.com.
About Endo International plc
Endo International plc
(NASDAQ: ENDP) is a highly-focused specialty branded and generics
pharmaceutical company delivering quality medicines to patients in
need through excellence in development, manufacturing and
commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 and Canadian securities legislation, including, but not
limited to, the statements by Mr. Coleman and Drs. Davis and
Chapas, as well as other statements regarding research and
development outcomes, efficacy, adverse reactions, market and
product potential and product availability. Statements including
words such as "believes," "expects," "anticipates," "intends,"
"estimates," "plan," "will," "may," "look forward," "intend,"
"guidance," "future" or similar expressions are forward-looking
statements. Because these statements reflect Endo's current views,
expectations and beliefs concerning future events, they involve
risks and uncertainties. Although Endo believes that these
forward-looking statements and information are based upon
reasonable assumptions and expectations, readers should not place
undue reliance on them, or any other forward-looking statements or
information in this news release. Investors should note that many
factors, as more fully described in the documents filed by Endo
with the Securities and Exchange Commission and with securities
regulators in Canada on the System
for Electronic Document Analysis and Retrieval, including under the
caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K
filings, and as otherwise enumerated herein or therein, could
affect Endo's future results and could cause Endo's actual results
to differ materially from those expressed in forward-looking
statements contained in this communication. The forward-looking
statements in this press release are qualified by these risk
factors. Endo assumes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise, except as may be required under
applicable securities laws.
References:
- Qwo™ package insert. Malvern,
PA: Endo Aesthetics LLC
- Zhang YZ, et al. Appl Environ Microbiol.
2015;81(18):6098-6107.
- Rossi AM, Katz BE. Dermatol Clin. 2014;32(1):51-59.
- Edkins TJ, et al. Clin Vaccine Immunol.
2012;19(4):562-569.
- Kaplan FT. Drugs Today (Barc). 2011;47(9):653-667.
- Hexsel DM, et al. Side-by-side comparison of areas with and
without cellulite depressions using magnetic resonance imaging.
Dermatol Surg. 2009;35(10):1471-7.
- Khan MH, et al. Treatment of cellulite: Part I.
Pathophysiology. J Am Acad Dermatol. 2010;62:361-70.
- Querleux B, et al. Anatomy and physiology of subcutaneous
adipose tissue by in vivo magnetic resonance imaging and
spectroscopy: Relationships with sex and presence of cellulite.
Skin Res Technol. 2002;8(2):118-24.
- Rudolph C, et al. Structural gender-dimorphism and the
biomechanics of the gluteal subcutaneous tissue – Implications for
the pathophysiology of cellulite. Plast Reconstr Surg.
2019;143(4):1077-86.
- Avram MM. Cellulite: a review of its physiology and treatment.
J Cosmet Laser Ther. 2005;7:1-5.
- Pierard GE, et al. Cellulite: from standing fat herniation to
hypodermal stretch marks. Am J Dermatopathol.
2000;22(1):34-7.
Endo
International plc:
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Media:
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Investors:
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Heather
Zoumas-Lubeski
(484)
216-6829
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Pravesh
Khandelwal
(845) 364-4833
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media.relations@endo.com
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relations.investor@endo.com
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SOURCE Endo International plc