DUBLIN, Oct. 7, 2022 /PRNewswire/ -- Endo International
plc (OTC: ENDPQ) announced today that data from studies of Endo
Aesthetics' Qwo® (collagenase clostridium
histolyticum-aaes), an FDA-approved injectable for the treatment of
moderate to severe cellulite in the buttocks of adult women, will
be presented during the American Society for Dermatologic Surgery
annual meeting, taking place now through October 10 in Denver,
CO.
The five new and modified oral presentations are below:
- NEW: Durability of Collagenase Clostridium
Histolyticum-aaes Treatment of Buttock Cellulite in Women:
Open-Label Extension Study Results Through 3 Years
-
- Authors: Michael H. Gold, MD;
David Hernandez, MD; Saji Vijayan, MBBS; Qinfang Xiang, PhD; Joely Kaufman-Janette, MD; Sabrina Guillen Fabi, MD
- NEW: Capturing Cellulite: A Practical Photography Guide
for the General Aesthetics Practice
-
- Authors: Sabrina Guillen Fabi,
MD, FAAD, FAACS; Autumn Murphy, BA;
Jill Edgecombe, BS; Mitchel P. Goldman, MD
- NEW: Visualizing the Arborisation of
Subdermal Septa: A Closer MRI View into the
3-Dimensionality Behind Cellulite
-
- Authors: Sebastian Cotofana, MD,
PhD; Jill Edgecombe, BS;
David Hernandez, MD; Lisa Metler, PA-C; Michael Alfertshofer, MD
- A Phase 2 Open-Label Study of Bruising Following Different
Interventions With Collagenase Clostridium
Histolyticum-aaes Treatment for Cellulite of the Buttocks in
Women
-
- Authors: Joely Kaufman-Janette,
MD; Michael H. Gold, MD;
David Hernandez, MD; Carrie Lewis, MS; Gongfu Zhou, PhD; James P. Tursi, MD; Saji
Vijayan, MBBS, D. Diab
- Direct Visualization of Dermal Thickness, Cellulite, and
Fibrous Bands Using High-Resolution Ultrasound
-
- Authors: Lisa Metler, PA-C;
Serena Chase, MBA; Jill
Edgecombe, BS; Brad Bengtson,
MD
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 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.7 Cellulite clinically presents
on the buttocks, thighs, lower abdomen and arms.8
It is known that cellulite is different from generalized
obesity.8 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.9 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.7
Weight gain can make cellulite more noticeable, but cellulite may
be present even in thin subjects.8
About Endo Aesthetics
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.
Endo Aesthetics is an Endo International plc (OTC: ENDPQ)
business. Learn more at www.endoaesthetics.com.
About Endo
Endo (OTC: ENDPQ) 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 passionate team
members around the globe collaborating to bring 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.
Cautionary Note Regarding Forward-Looking
Statements
Certain information in this press release may be
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 and any applicable
Canadian securities legislation, including, but not limited to, the
presentation of data from studies and any other statements that
refer to expected, estimated or anticipated future results or that
do not relate solely to historical facts. Statements including
words or phrases such as "believe," "expect," "anticipate,"
"intend," "estimate," "plan," "will," "may," "look forward,"
"intend," "guidance," "future," "potential" or similar expressions
are forward-looking statements. All forward-looking statements in
this communication reflect the Company's current views as of the
date of this communication about its plans, intentions,
expectations, strategies and prospects, which are based on the
information currently available to it and on assumptions it has
made. Actual results may differ materially and adversely from
current expectations based on a number of factors, including, among
other things, the following: the outcome of the Company's
contingency planning and restructuring activities; the timing,
impact or results of any pending or future litigation,
investigations, proceedings or claims, including opioid, tax and
antitrust related matters; actual or contingent liabilities;
settlement discussions or negotiations; the Company's liquidity,
financial performance, cash position and operations; the Company's
strategy; risks and uncertainties associated with Chapter 11
proceedings; the negative impacts on the Company's businesses as a
result of filing for and operating under Chapter 11 protection; the
time, terms and ability to confirm a sale of the Company's
businesses under Section 363 of the U.S. Bankruptcy Code; the
adequacy of the capital resources of the Company's businesses and
the difficulty in forecasting the liquidity requirements of the
operations of the Company's businesses; the unpredictability of the
Company's financial results while in Chapter 11 proceedings; the
Company's ability to discharge claims in Chapter 11 proceedings;
negotiations with the holders of the Company's indebtedness and its
trade creditors and other significant creditors; risks and
uncertainties with performing under the terms of the restructuring
support agreement and any other arrangement with lenders or
creditors while in Chapter 11 proceedings; the Company's ability to
conduct business as usual; the Company's ability to continue to
serve customers, suppliers and other business partners at the high
level of service and performance they have come to expect from the
Company; the Company's ability to continue to pay employees,
suppliers and vendors; the ability to control costs during Chapter
11 proceedings; adverse litigation; the risk that the Company's
Chapter 11 Cases may be converted to cases under Chapter 7 of the
Bankruptcy Code; the Company's ability to secure operating capital;
the Company's ability to take advantage of opportunities to acquire
assets with upside potential; the Company's ability to execute on
its strategic plan to pursue, evaluate and close an asset sale of
the Company's businesses pursuant to Section 363 of the U.S.
Bankruptcy Code; the impact of competition, including the loss of
exclusivity and generic competition for VASOSTRICT®; our
ability to satisfy judgments or settlements or pursue appeals
including bonding requirements; our ability to adjust to changing
market conditions; our ability to attract and retain key personnel;
our inability to maintain compliance with financial covenants and
operating obligations which would expose us to potential events of
default under our outstanding indebtedness; our ability to incur
additional debt or equity financing for working capital, capital
expenditures, business development, debt service requirements,
acquisitions or general corporate or other purposes; our ability to
refinance our indebtedness; a significant reduction in our
short-term or long-term revenues which could cause us to be unable
to fund our operations and liquidity needs or repay indebtedness;
supply chain interruptions or difficulties; changes in competitive
or market conditions; changes in legislation or regulatory
developments; our ability to obtain and maintain adequate
protection for our intellectual property rights; the timing and
uncertainty of the results of both the research and development and
regulatory processes, including regulatory decisions, product
recalls, withdrawals and other unusual items; domestic and foreign
health care and cost containment reforms, including government
pricing, tax and reimbursement policies; technological advances and
patents obtained by competitors; the performance, including the
approval, introduction, and consumer and physician acceptance of
new products and the continuing acceptance of currently marketed
products; our ability to integrate any newly acquired products into
our portfolio and achieve any financial or commercial expectations;
the impact that known and unknown side effects may have on market
perception and consumer preference for our products; the
effectiveness of advertising and other promotional campaigns; the
timely and successful implementation of any strategic initiatives;
unfavorable publicity regarding the misuse of opioids; the
uncertainty associated with the identification of and successful
consummation and execution of external corporate development
initiatives and strategic partnering transactions; our ability to
advance our strategic priorities, develop our product pipeline and
continue to develop the market for QWO® and other
products; and our ability to obtain and successfully manufacture,
maintain and distribute a sufficient supply of products to meet
market demand in a timely manner. In addition, U.S. and
international economic conditions, including consumer confidence
and debt levels, inflation, taxation, changes in interest and
currency exchange rates, international relations, capital and
credit availability, the status of financial markets and
institutions, the impact of and response to the ongoing COVID-19
pandemic and the impact of continued economic volatility, can
materially affect our results. Therefore, the reader is cautioned
not to rely on these forward-looking statements. Endo expressly
disclaims any intent or obligation to update these forward-looking
statements, except as required to do so by law.
References:
- Hexsel DM Abreu M, Rodrigues TC, 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, Victor F, Rao B, et al. Treatment of cellulite: Part
I. Pathophysiology. J Am Acad Dermatol.
2010;62(3):361-70.
- Querleux B, Cornillon C, Jolivet 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, Ran LY, Li CY, et al. Diversity, structures, and
collagen-degrading mechanisms of bacterial collagenolytic
proteases. Appl Environ Microbiol.
2015;81(18):6098-6107.
- Rossi AM, Katz BE. A modern approach to the treatment of
cellulite. Dermatol Clin. 2014;32(1):51-59.
- Hexsel D, Zechmeister do Prodo D, Goldman M. Topical Management
of Cellulite. In: Goldman M, Hexsel D, eds. Cellulite:
Pathophysiology and Treatment. 2nd ed. Boca Raton: CRC Press; 2010:62-68.
- Rudolph C, Hladik C, Hamade H, 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, Nizet JL, Pierard-Franchimont C. Cellulite: from
standing fat herniation to hypodermal stretch marks. Am J
Dermatopathol. 2000;22(1):34-7.
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