DUBLIN, Sept. 24, 2020 /CNW/ -- Endo International
plc (NASDAQ:ENDP) today announced that it will present data
relevant to the use of Qwo™ (collagenase clostridium
histolyticum-aaes) for the treatment of moderate to severe
cellulite in the buttocks of adult women during Vegas Cosmetic
Surgery & Aesthetic Dermatology (VCS). This data will be
highlighted in two oral presentations during the virtual VCS
symposium taking place September 24 –
27, 2020.
On Thursday, September
24th a presentation titled "Injectable Cellulite
Treatment," will be given by Michael
Gold, M.D., F.A.A.D., a board-certified dermatologist in
Nashville, TN. This presentation
will include a general overview of collagenase clostridium
histolyticum-aaes and will review data from the product's phase 3
pooled trial analyses.
On Saturday, September
26th Sachin M.
Shridharani, M.D., F.A.C.S., will present "Injectable
Cellulite Treatment - Collagenase Clostridium Histolyticum-aaes
Effect on Tissue Histology." During this presentation, Dr.
Shridharani, a board-certified plastic surgeon in New York, NY, will outline findings from two
new histology studies that were designed to characterize QWO's
subdermal impact and investigate the most frequently reported
adverse event, injection site bruising.
The data being presented by Dr. Shridharani introduces Enzymatic
Subcision and Remodeling™ (ESR™), which is thought to be a key
component of collagenase clostridium histolyticum-aaes' mechanism
of action. QWO breaks down the mature, collagen-rich septae which
are one cause of cellulite dimples and stimulates the onset of new
collagen for a smoother looking appearance1,2.
"We are pleased that these data will be presented at Vegas
Cosmetic Surgery & Aesthetic Dermatology, and as we prepare to
launch QWO in spring 2021, we are committed to ensuring aesthetic
healthcare providers have continued access to relevant research on
the product," said Matthew Davis,
M.D., R.Ph., Senior Vice President and Chief Medical Officer of
Endo.
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.3,4 The presence of cellulite is
associated with changes in dermal thickness and in the fat cells
and connective tissue below the skin.5 A primary
factor in the cause of the condition is the collagen containing
septae which attach the skin to the underlying fascia
layers.6,7 The septae tether the skin which, with
additional contributing protrusions of subcutaneous fat, causes the
surface dimpling characteristic of
cellulite.8,9 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.10 Cellulite clinically presents on the
buttocks, thighs, lower abdomen and arms.
It is known that cellulite is different from generalized
obesity.11 In generalized obesity, adipocytes
undergo hypertrophy and hyperplasia that is not limited to the
pelvis, thighs, and abdomen.4 In areas of
cellulite, characteristic large, metabolically stable adipocytes
have physiologic and biochemical properties that differ from
adipose tissue located elsewhere.12 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.10,12 Weight gain can make cellulite
more noticeable, but cellulite may be present even in thin
subjects.11
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 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. Endo has global headquarters in
Dublin, Ireland and U.S.
headquarters in Malvern,
Pennsylvania. 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 Dr. Davis 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
- Shridharani, Sachin (2020, September). Injectable Cellulite
Treatment - Collagenase Clostridium Histolyticum-aaes Effect on
Tissue Histology. Presented at Vegas Cosmetic Surgery &
Aesthetic Dermatology, virtual meeting.
- 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