Endo's Qwo® (collagenase clostridium histolyticum-aaes) Data to Be Presented at Cosmetic Bootcamp 2021

Rhea-AI Summary

Endo International plc (NASDAQ: ENDP) announced the presentation of new data regarding Qwo^® (collagenase clostridium histolyticum-aaes) for cellulite treatment at the Cosmetic Bootcamp Summer Event held from June 24-27, 2021, in Aspen, CO. The data includes findings from a Phase 4 trial on bruising mitigation and interim results of real-world effectiveness. Qwo, FDA-approved in July 2020 for moderate to severe cellulite in adult women, is contraindicated in patients with hypersensitivity to collagenase or with infections at injection sites. Safety precautions and adverse reactions are also detailed in the release.

Positive

• Presentation of new data may enhance Qwo's market positioning.
• Qwo is FDA-approved and indicated for moderate to severe cellulite treatment in women.

Negative

• 84% of subjects experienced injection site bruising in clinical trials.
• Serious hypersensitivity reactions, including anaphylaxis, have been reported.

DUBLIN, June 24, 2021 /PRNewswire/ -- Endo International plc (NASDAQ:ENDP) announced today that data from studies 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 Cosmetic Bootcamp Summer Event.

This data will be highlighted in three e-posters that will be available during the virtual and in-person meeting taking place in Aspen, CO, June 24–27, 2021.

• New data: Assessment of Mitigation Treatments on Injection-Site Bruising of Collagenase Clostridium Histolyticum-aaes Treatment of Buttock Cellulite in Women: A Phase 4, Open-Label Trial
• Authors: Steven H. Dayan, M.D.; Brian S. Biesman, M.D.; Suzanne Kilmer, M.D.; Kadriye Ciftci, M.D., Ph.D.; Jill Edgecombe, B.S.; Genzhou Liu, Ph.D.; Michael P. McLane, Ph.D.; Brenda LaTowsky, M.D.
• Real-World Effectiveness and Safety of Collagenase Clostridium Histolyticum-aaes Injections for the Treatment of Thigh Cellulite in Women: An Interim Analysis
• Authors: Melanie Palm, M.D., M.B.A.; John H. Joseph, M.D.; Deanne Mraz Robinson, M.D.; Ashish C. Bhatia, M.D.; Sachin M. Shridharani, M.D.; Steven H. Dayan, M.D.; Lisa Donofrio, M.D.; Jose R. Montes, M.D.; Genzhou Liu, Ph.D.; David Hernandez, M.D.; Jill Edgecombe, B.S.; Saji Vijayan, M.B.B.S.; Sabrina Guillen Fabi, M.D.
• Influence of Body Mass Index and Age on Response to Collagenase Clostridium Histolyticum-aaes Treatment of Buttock Cellulite: A Pooled Analysis of Two Phase 3 Randomized, Placebo-Controlled Trials
• • Authors: Mary P. Lupo, M.D.; Edward Lain, M.D.; Lawrence S. Bass, M.D.; Michael P. McLane, Ph.D.; Saji Vijayan, M.B.B.S.; Genzhou Liu, Ph.D.; Jill Edgecombe, B.S.; Mitchel P. Goldman, M.D.

Posters will be available online throughout the meeting.

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
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 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 any applicable 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:

1. 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. 
2. Khan MH, et al. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol. 2010;62:361-70.
3. 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.
4. Zhang YZ, et al. Appl Environ Microbiol. 2015;81(18):6098-6107. 
5. Rossi AM, Katz BE. Dermatol Clin. 2014;32(1):51-59. 
6. Edkins TJ, et al. Clin Vaccine Immunol. 2012;19(4):562-569. 
7. Kaplan FT. Drugs Today (Barc). 2011;47(9):653-667.
8. 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.
9. Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 2005;7:1-5.
10. 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

FAQ

What is Qwo and what is its indication?

Qwo is a collagenase injectable treatment approved by the FDA for moderate to severe cellulite in the buttocks of adult women.

When was Qwo approved by the FDA?

Qwo received FDA approval in July 2020.

What event will present data on Qwo?

Data on Qwo will be presented at the Cosmetic Bootcamp Summer Event from June 24-27, 2021.

What adverse reactions are associated with Qwo?

Common adverse reactions reported include bruising, pain, nodule, and pruritus at the injection site.

What is the significance of the new data being presented about Qwo?

The new data includes findings on treatment effectiveness and safety, which could influence Qwo's market potential.