DUBLIN, May 5, 2022
/PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today
announced the upcoming launch of a new clinical study relevant to
the use of Qwo® (collagenase clostridium
histolyticum-aaes) for the treatment of moderate to severe
cellulite in the buttocks of adult women. The design of the study
will be featured during the annual Symposium for Cosmetic
Advances & Laser
Education (SCALE) multidisciplinary aesthetic
medicine meeting, taking place in Nashville, TN, May
11-15, 2022.
The poster presentation, titled "APHRODITE-1: A Phase 2 Study of
Different Interventions to Reduce Bruising Following Collagenase
Clostridium Histolyticum-aaes Treatment for Cellulite of the
Buttocks in Women," will share the objectives and unique design of
this multi-cohort study which will test different interventions to
assess their potential impact on reduction of bruising. The study
has been created with the flexibility to add cohorts in order to
test additional interventions over time if desired.
"I appreciate Endo's continued investment in research and
development," said Joely
Kaufman-Janette, M.D., lead author, principal investigator
and board-certified dermatologist. "My patients who are bothered by
their cellulite are excited about QWO. This new study, as well as
future research, may have the potential to enhance their
experience."
"We look forward to launching this study later this quarter and
are committed to continuing to offer aesthetic healthcare providers
data not only on the safety and efficacy of QWO, but also on the
real-world experiences with this treatment," said James P. Tursi, M.D., Executive Vice
President, Global Research & Development at Endo.
All poster presentations will be available for SCALE attendees
live at the meeting and will be published on the SCALE website
once the meeting concludes.
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 for QWO,
including Patient Information.
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 A
primary factor in the cause of the condition is the
collagen-containing septae which attach the skin to the underlying
fascia layers.3,4 The septae tether the skin which, with
additional contributing protrusions of subcutaneous fat, causes the
surface dimpling characteristic of cellulite.5,6 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.
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 (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 passionate team members around the globe
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
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
statements by Drs. Kaufman-Janette and Tursi and any statements
relating to clinical trials, future research, timelines or
expectations. Statements including words or phrases such as
"believe," "expect," "anticipate," "intend," "estimate," "plan,"
"will," "may," "look forward," "intend," "future," "potential" or
similar expressions are forward-looking statements. All
forward-looking statements in this press release reflect Endo's
current expectations of future events based on existing trends and
information and represent Endo's judgment only as of the date of
this press release. Actual results may differ materially and
adversely from current expectations based on a number of factors
affecting Endo's businesses, including, among other things, the
following: the outcome of our strategic review, contingency
planning and any potential restructuring; the timing, impact or
results of any pending or future litigation, investigations,
proceedings or claims, including opioid, tax and antitrust matters;
actual or contingent liabilities; settlement discussions or
negotiations; the impact of competition including loss of
exclusivity and generic competition; our ability to satisfy
judgments or settlements or to pursue appeals including bonding
requirements; our ability to adjust to changing market conditions;
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 refinance our outstanding 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; the performance of Qwo®, including consumer and
physician acceptance; the impact that known and unknown side
effects may have on market perception and consumer preference; the
effectiveness of advertising and other promotional campaigns;
unfavorable publicity regarding the misuse of opioids; and our
ability to develop our product pipeline and to continue to develop
the market for Qwo® and other products. The occurrence
or possibility of any such result has caused us to engage, and may
result in further engagement in strategic reviews that ultimately
may result in our pursuing one or more significant corporate
transactions or other remedial measures, including on a
preventative or proactive basis. Those remedial measures could
include a potential corporate reorganization, restructuring or
bankruptcy filing involving all or a portion of our business, asset
sales or other divestitures, cost-saving initiatives, corporate
realignments or strategic partnerships. Some of these measures
could take significant time to implement and others may require
judicial or other third-party approval. Any such actions may be
complex, could entail significant costs and charges or could
otherwise negatively impact shareholder value, and there can be no
assurance that we will be able to accomplish any of these
alternatives on terms acceptable to us, or at all, or that they
will result in their intended benefits. 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.
Additional information concerning risk factors, including those
referenced above, can be found in press releases issued by Endo, as
well as Endo's public periodic filings with the U.S. Securities and
Exchange Commission and with securities regulators in Canada, including the discussion under the
heading "Risk Factors" in Endo's most recent Annual Report on Form
10-K and any subsequent Quarterly Reports on Form 10-Q or other
filings with the U.S. Securities and Exchange Commission.
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.
- 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.
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SOURCE Endo International plc