Qwo® data from Endo (collagenase clostridium histolyticum-aaes) to be presented at the 2021 aesthetic meeting



DUBLIN, April 29, 2021 / PRNewswire / – Endo International plc (NASDAQ: ENDP) today announced that Endo Aesthetics’ Qwo usage data® (collagenase clostridium histolyticum-aaes), which received FDA approval in July 2020 for the treatment of moderate to severe cellulitis of the buttocks of adult women, will be presented during The 2021 aesthetic encounter.

This data will be highlighted during two oral presentations during the virtual and in-person meeting that will take place in Miami, Florida April 29 to May 3, 2021.

  • “Reduction of dimple size in women with cellulitis of the buttocks treated with Clostridium Histolyticum-aaes collagenase”; Lawrence bass, MD, Medical Director and Founder, Bass Plastic Surgery, PLLC and QWO Clinical Trials Investigator; Sunday May 2
  • “Real-world efficacy and safety of Clostridium histolyticum-aaes collagenase injections for the treatment of thigh cellulitis in women: an interim review”; Sachin shridharani, MD, FACS, founder, LUXURGERY©, and investigator of the QWO clinical trial; Sunday May 2

QWO will also be discussed during The Aesthetic Meeting’s highly respected Premier Global Hot Topics program on Friday April 30.

INDICATION
QWO is indicated for the treatment of moderate to severe cellulitis of 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 in 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 clostridium histolyticum collagenase. If such a reaction occurs, another injection of QWO should be stopped and appropriate medical treatment should be started immediately. Advise patients to seek medical attention immediately if they experience symptoms of severe hypersensitivity reactions.

Bruising at the injection site
In clinical trials, 84% of subjects treated with QWO developed bruising at the injection site. Subjects with bleeding disorders or using anticoagulants or antiplatelet agents (except those taking ≤ 150 mg aspirin per day) were excluded from participation in trials 1 and 2.

QWO should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet drugs (except those taking ≤ 150 mg aspirin per day) or anticoagulant therapy.

Substitution of collagenase products
QWO should not be replaced by other injectable collagenase products. QWO is not intended for the treatment of Peyronie’s disease or Dupuytren’s contracture.

SIDE EFFECTS
In clinical trials, the most frequently reported adverse reactions in patients treated with an incidence of QWO ≥ 10% were at the injection site: bruising, pain, lump and pruritus.

Click for full Prescribing information for QWO.

About cellulite
Cellulitis is a localized alteration in the contour of the skin that has been reported in over 90% of post-puberty women and affects women of all races and ethnicities.1.2 The presence of cellulite is associated with changes in the thickness of the dermis and fat cells and connective tissue under the skin.3 A main factor in the cause of the disease is the collagen containing septa that attach the skin to the underlying fascia layers.4.5 The septa attach the skin which, along with additional contributory protuberances of subcutaneous fat, causes the characteristic surface dimpling of cellulite.6.7 These fibrous septa are oriented differently with varying thickness in women than in men, which informs our understanding of cellulite as a sex-related condition.8 Cellulite is clinically present on the buttocks, thighs, lower abdomen and arms.

We know that cellulite is different from generalized obesity.9 In generalized obesity, the fat cells undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs and abdomen.2 In areas of cellulite, the characteristic large adipocytes, metabolically stable, have physiological and biochemical properties that differ from adipose tissue elsewhere.ten An anatomical study done in 2019 found that women had a higher fat lobule height than men, which may also contribute to the mattress-like appearance due to the tension of the fibrous partitions.8.10 Weight gain can make cellulite more noticeable, but cellulite can be present even in thin people.9

About Endo Aesthetics LLC
Endo Aesthetics embarks on a mission dedicated to pushing the boundaries of aesthetic art. Driven by world-class research and development, Endo Aesthetics offers solutions to address unmet needs starting with the first FDA-approved injectable treatment for cellulite in the buttocks. Based in Malvern, Pennsylvania, Endo Aesthetics is a business of Endo International plc (NASDAQ: ENDP). Learn more about www.endoaesthetics.com.

About Endo
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best lives through the provision of quality life-enhancing therapies. Our decades of proven success come from a global team of passionate employees who work together to deliver the best treatments. Together, we boldly turn knowledge into treatment for those who need it, when they need it. Learn more about 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 Canadian securities laws, including, but not limited to, statements regarding the results of research and development, safety, efficacy, efficacy, side effects, market and the potential and availability of products. Statements including words such as “believes”, “expects”, “plans”, “intends”, “estimates”, “will plan”, “will”, “may”, “look to the future” “,” intend “,” guide “, Expressions” future “or the like are forward-looking statements. Since these statements reflect Endo’s current opinions, expectations and beliefs regarding future events, they involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based on reasonable assumptions and expectations, readers should not place undue reliance on such statements or any other forward-looking statements or information contained in this press release. Investors should note that many factors, as described in more detail in documents filed by Endo with the Securities and Exchange Commission and with securities regulatory authorities in Canada on the Electronic Document Analysis and Retrieval System , including under the heading “Risk Factors” of the Endo Form The 10-K, Form 10-Q and Form 8-K filings, and as listed herein or herein, could affect future results of Endo and could cause the actual results of Endo to differ materially from those expressed in the forward-looking statements contained in this communication. The forward-looking statements contained 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 to the extent required by applicable securities laws.

The 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 and biomechanical gender dimorphism of the gluteal subcutaneous tissue – Implications for the pathophysiology of cellulitis. 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 fatty hernia to hypodermic stretch marks. Am J Dermatopathol. 2000; 22 (1): 34-7.

SOURCE Endo International plc

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