DUBLIN, April 13, 2021 /PRNewswire/ -- Endo International
plc (NASDAQ: ENDP) today announced that Phase 3 data evaluating
Qwo® (collagenase clostridium histolyticum-aaes) for the
treatment of moderate to severe cellulite in the buttocks of adult
women was published in Dermatologic Surgery, the official
journal of the American Society for Dermatologic Surgery. In
addition to Phase 3 studies, the publication also includes a
supplemental video that demonstrates the injection techniques for
QWO.
The Phase 3 studies, conducted from February 2018 to September
2018, demonstrated that QWO provides a clinically meaningful
improvement in the appearance of moderate to severe cellulite in
the buttocks of adult women compared to placebo. QWO received FDA
approval in July 2020 and is the
first and only injectable treatment for moderate to severe
cellulite in the buttocks of adult women.
"The data, from the largest cellulite studies ever conducted,
provides further evidence that QWO may be an effective treatment
for women with a variety of skin types who dislike the dimples on
their buttocks," said Joely
Kaufman-Janette, M.D., lead author, principal investigator
and board-certified dermatologist at Skin
Associates of South Florida.
The RELEASE-1 and RELEASE-2 Phase 3 studies, which were
identically designed, randomized, double blinded and
placebo-controlled, assessed the efficacy and safety of QWO for the
treatment of cellulite in women. A greater percentage of the 843
women treated during the studies (QWO vs. placebo: RELEASE 1, n=210
vs n=213; RELEASE-2, n=214 vs n=206) met the primary endpoint of a
composite 2-level response on a 5-point cellulite severity scale.
Over half of the women treated with QWO in both studies met the
secondary endpoint, a 1-level improvement in the patient reported
assessment.
"The secondary endpoints in these studies reaffirm that
many study participants and their doctors found that QWO delivered
a clinically relevant improvement in the appearance of cellulite,
and we are thrilled to have this data published in the
peer-reviewed Dermatologic Surgery journal," said
Ravi Tayi, M.D., M.P.H., Endo's
Chief Medical Officer. "As we continue to train doctors on the use
of QWO, we remain committed to sharing timely and relevant data
with aesthetic healthcare practitioners."
INDICATION
QWO is indicated for the treatment of
moderate to severe cellulite in the buttocks of adult women.
IMPORTANT SAFETY INFORMATION FOR
QWO
CONTRAINDICATIONS
QWO is contraindicated in patients with a history of
hypersensitivity to collagenase or to any of the excipients or the
presence of infection at the injection sites.
WARNINGS AND PRECAUTIONS
Hypersensitivity
Reactions
Serious hypersensitivity reactions including
anaphylaxis have been reported with the use of collagenase
clostridium histolyticum. If such a reaction occurs, further
injection of QWO should be discontinued and appropriate medical
therapy immediately instituted. Advise patients to seek immediate
medical attention if they experience any symptoms of serious
hypersensitivity reactions.
Injection Site Bruising
In clinical trials, 84% of
subjects treated with QWO experienced injection site bruising.
Subjects with coagulation disorders or using anticoagulant or
antiplatelet medications (except those taking ≤150 mg aspirin
daily) were excluded from participating in Trials 1 and 2.
QWO should be used with caution in patients with bleeding
abnormalities or who are currently being treated with antiplatelet
(except those taking ≤150 mg aspirin daily) or anticoagulant
therapy.
Substitution of Collagenase Products
QWO must not be
substituted with other injectable collagenase products.
QWO is not intended for the treatment of Peyronie's Disease or
Dupuytren's Contracture.
ADVERSE REACTIONS
In clinical trials, the most
commonly reported adverse reactions in patients treated with QWO
with an incidence ≥ 10% were at the injection site: bruising, pain,
nodule and pruritus.
Click for Full Prescribing
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.1,2 The
presence of cellulite is associated with changes in dermal
thickness and in the fat cells and connective tissue below the
skin.3 A primary factor in the cause of the condition is
the collagen containing septae which attach the skin to the
underlying fascia layers.4,5 The septae tether the skin
which, with additional contributing protrusions of subcutaneous
fat, causes the surface dimpling characteristic of
cellulite.6,7 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.8 Cellulite clinically presents on the
buttocks, thighs, lower abdomen and arms.
It is known that cellulite is different from generalized
obesity.9 In generalized obesity, adipocytes undergo
hypertrophy and hyperplasia that is not limited to the pelvis,
thighs, and abdomen.2 In areas of cellulite,
characteristic large, metabolically stable adipocytes have
physiologic and biochemical properties that differ from adipose
tissue located elsewhere.10 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.8,10 Weight gain can make cellulite more
noticeable, but cellulite may be present even in thin
subjects.9
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 Endo International plc (NASDAQ: ENDP)
business. Learn more at www.endoaesthetics.com.
About Endo
Endo (NASDAQ: ENDP) is a specialty
pharmaceutical company committed to helping everyone we serve live
their best life through the delivery of quality, life-enhancing
therapies. Our decades of proven success come from a global team of
passionate employees collaborating to bring the best treatments
forward. Together, we boldly transform insights into treatments
benefiting those who need them, when they need them. Learn more at
www.endo.com or connect with us on LinkedIn.
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 Drs. Kaufman-Janette and Tayi as well as other
statements regarding research and development outcomes, efficacy,
adverse reactions, market and product potential, product launch
timing 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:
- 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.
- 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.
- 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.
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