U.S. FDA Approves Qwo™ (collagenase clostridium histolyticum-aaes), the First Injectable Treatment for Cellulite

DUBLIN, July 7, 2020 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that it received U.S. Food and Drug Administration (FDA) approval of Qwo™ (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO is the first FDA-approved injectable treatment for cellulite.

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"Today's FDA approval of QWO is a key achievement in the continued execution of Endo's long-term strategy, especially as it relates to building our portfolio and capabilities for the future," said Blaise Coleman, President and Chief Executive Officer of Endo. "As Endo embarks on an exciting new journey into medical aesthetics, we look forward to bringing this innovative treatment to market through our Endo Aesthetics organization."

While cellulite is known to be a multifactorial condition, a primary contributing factor is the fibrous connective tissue, called the "fibrous septae," which connect the skin perpendicularly to the fascia below.^2,3 These fibrous septae tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as "dimpling."^4,5 When injected into the treatment area, QWO is thought to release the fibrous septae enzymatically by specifically targeting Types 1 and 3 collagen, which may result in smoothing of the skin and an improved appearance of cellulite.¹ 

"Endo recognized a significant unmet need for an effective and non-invasive injectable treatment for cellulite, which led us to conduct the largest clinical trials in the history of cellulite investigation in the United States," said Matthew Davis, M.D., R.Ph., Senior Vice President and Chief Medical Officer of Endo. "Supported by rigorous research, testing and development processes, we are proud to have received FDA approval of the first injectable treatment for cellulite in the buttocks and we look forward to delivering QWO to the aesthetics community and their adult female patients."

Side effects of QWO included injection site bruising, pain, areas of hardness and itching in the treatment area.  Please see Important Safety Information below for more details.

"QWO could be a game-changer for many women with cellulite," said Anne Chapas, M.D., a board-certified dermatologist at Union Square Laser Dermatology in New York City. "I am thrilled there will now be an FDA-approved injectable treatment option proven to address a root cause of cellulite. What is exciting about QWO is that it is a cutting-edge cellulite treatment, without the cutting."

QWO is expected to be available throughout the United States at aesthetic healthcare practitioner's offices starting in Spring 2021. Physicians and consumers are encouraged to visit www.QWO.com and sign up for updates on product availability.

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, including Patient 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.^6,7 The presence of cellulite is associated with changes in dermal thickness and in the fat cells and connective tissue below the skin.⁸ A primary factor in the cause of the condition is the collagen containing septae which attach the skin to the underlying fascia layers.^2,3 The septae tether the skin which, with additional contributing protrusions of subcutaneous fat, causes the surface dimpling characteristic of cellulite.^4,5 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.⁹ Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms.⁶ 

It is known that cellulite is different from generalized obesity.¹⁰ In generalized obesity, adipocytes undergo hypertrophy and hyperplasia that is not limited to the pelvis, thighs, and abdomen.⁷ In areas of cellulite, characteristic large, metabolically stable adipocytes have physiologic and biochemical properties that differ from adipose tissue located elsewhere.¹¹ 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.^9,11  Weight gain can make cellulite more noticeable, but cellulite may be present even in thin subjects.¹⁰

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 highly-focused specialty branded and generics pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. 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 Mr. Coleman and Drs. Davis and Chapas, 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:

1. Qwo™ package insert. Malvern, PA: Endo Aesthetics LLC
2. Zhang YZ, et al. Appl Environ Microbiol. 2015;81(18):6098-6107.
3. Rossi AM, Katz BE. Dermatol Clin. 2014;32(1):51-59.
4. Edkins TJ, et al. Clin Vaccine Immunol. 2012;19(4):562-569.
5. Kaplan FT. Drugs Today (Barc). 2011;47(9):653-667.
6. 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.
7. Khan MH, et al. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol. 2010;62:361-70.
8. 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.
9. 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.
10. Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 2005;7:1-5.
11. Pierard GE, et al. Cellulite: from standing fat herniation to hypodermal stretch marks. Am J Dermatopathol. 2000;22(1):34-7.