Endo Presents New Qwo® (collagenase clostridium histolyticum-aaes) Data at the American Society for Dermatologic Surgery's Annual Meeting
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
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
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
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
Lisa Metler, PA-C; Serena Chase, MBA; Jill Edgecombe, BS; Brad Bengtson, MD
Qwo® is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.
IMPORTANT SAFETY INFORMATION FOR QWO
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
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.
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.
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 (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
- 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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