DUBLIN, April 29, 2021 /PRNewswire/ -- Endo International
plc (NASDAQ: ENDP) announced today that data relevant to the use of
Endo Aesthetics' Qwo® (collagenase clostridium
histolyticum-aaes), which received FDA approval in July 2020 for the treatment of moderate to severe
cellulite in the buttocks of adult women, will be presented during
The Aesthetic Meeting 2021.
This data will be highlighted in two oral presentations during
the virtual and in-person meeting taking place in Miami, FL April 29–May 3, 2021.
- "Reduction in Dimple Volume in Women With Buttock Cellulite
Treated With Collagenase Clostridium Histolyticum-aaes;"
Lawrence Bass, M.D., medical
director and founder, Bass Plastic Surgery, PLLC, and QWO clinical
trial investigator; Sunday, May
2
- "Real-World Effectiveness and Safety of Collagenase Clostridium
Histolyticum-aaes Injections for the Treatment of Thigh Cellulite
in Women: An Interim Analysis;" Sachin
Shridharani, M.D., F.A.C.S., founder,
LUXURGERY©, and QWO clinical trial
investigator; Sunday, May 2
QWO will also be discussed during The Aesthetic Meeting's
well-respected Premier Global Hot Topics program on Friday, April 30.
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
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, statements regarding research and development outcomes,
safety, efficacy, effectiveness, 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:
- 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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SOURCE Endo International plc