Endo Presents Dupuytren Contracture Data at the IFSSH and IFSHT Triennial Congress

Rhea-AI Summary

Endo (OTCQX: NDOI) announced the presentation of data regarding XIAFLEX® (collagenase clostridium histolyticum) for treating recurrent Dupuytren contracture after surgical correction at the IFSSH and IFSHT Triennial Congress (March 24-28, 2025).

Dupuytren contracture, affecting an estimated 17 million Americans, is a progressive hand condition where collagen cords form under the palm's skin, causing fingers to pull inward. The Phase 4 retrospective study data explores XIAFLEX® as an alternative to repeat surgery for patients experiencing recurrent deformity after initial successful surgery.

Dr. Clayton A. Peimer, Adjunct Clinical Professor of Orthopedics at Brown University's Warren Alpert Medical School and lead study author, emphasized the importance of these findings for healthcare providers managing recurrent cases of Dupuytren contracture.

Positive

• Large addressable market with 17 million Americans affected by the condition
• XIAFLEX offers non-surgical alternative for recurrent cases
• Phase 4 study data strengthens clinical evidence for XIAFLEX efficacy

Negative

• None.

MALVERN, Pa., March 24, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that data related to the use of XIAFLEX^® (collagenase clostridium histolyticum, or CCH) for the treatment of recurrence of Dupuytren contracture following surgical correction will be presented during the Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH) and International Federation of Societies for Hand Therapy (IFSHT), taking place March 24-28, 2025.

Dupuytren contracture is a progressive hand condition in which a collagen rope-like cord forms beneath the skin of the palm, pulling fingers inward toward the palm.^1,2 It affects an estimated 17 million Americans.^3,4*

"These findings may help healthcare providers manage Dupuytren contracture in patients experiencing a recurrent deformity following initially successful surgery," said Dr. Clayton A. Peimer, Adjunct Clinical Professor of Orthopedics at the Warren Alpert Medical School of Brown University, and lead author of the study. "The use of collagenase in these cases provides an alternative to repeat surgery. I look forward to sharing this information with the medical community so that we can further enhance our understanding of treatment options for recurrent Dupuytren contracture and, ultimately, improve patient outcomes."

The presentation covers data from the Phase 4 retrospective study of treatment with XIAFLEX in Dupuytren contracture patients with disease recurrence after surgical correction.

The Endo-sponsored presentation is below:

• Treatment of Dupuytren Contracture Recurrence After Surgery with Collagenase Clostridium Histolyticum: A Retrospective Multicenter Series
• Authors: Clayton A. Peimer, MD; Marie A. Badalamente, PhD; Philip Blazar, MD; Keith A. Denkler, MD; William Dzwierzynski, MD; Mark Elzik, MD; F. Thomas D. Kaplan, MD; Jason A. Nydick, DO; Gary M. Pess, MD; James Verheyden, MD; Mark A. Vitale, MD; Jeffrey Andrews, MS; Qinfang Xiang, PhD; David Hurley, MD; Lawrence C. Hurst, MD

About the Study
This Phase 4, multicenter, noninterventional, retrospective study analyzed medical records collected from 10 clinical centers in the United States (U.S.). Patients were included who experienced recurrence of Dupuytren contracture ≥ 6 months after a previously successful surgical correction and were then treated with collagenase clostridium histolyticum (CCH) between January 1, 2010 and August 15, 2020. Primary endpoints were the measured joint contracture change from baseline, at first and last clinical evaluation within 12 months of CCH treatment of metacarpophalangeal and proximal interphalangeal joint contractures. Secondary endpoints were clinical success (percentage of joints with reduction in contracture to 0–5°) and adverse events.

Results from this Phase 4 retrospective study demonstrated that CCH was effective and well tolerated for the treatment of Dupuytren contracture recurrence in patients after surgery. Most adverse events were rated as mild in severity and there were no reported treatment-related serious adverse events.

About Dupuytren Contracture
Dupuytren contracture is a lifelong condition that may get worse over time. It's caused by a buildup of collagen in the hand, which forms a rope-like cord that pulls fingers toward the palm so they can't be straightened. As Dupuytren contracture progresses, it may become difficult for individuals to use their hand(s) for daily tasks and activities.^1,2

WHAT IS XIAFLEX^®?

XIAFLEX is a prescription medicine used to treat adults with Dupuytren's contracture when a "cord" can be felt. It is not known if XIAFLEX is safe and effective in children under the age of 18.

IMPORTANT SAFETY INFORMATION FOR XIAFLEX

Do not receive XIAFLEX if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including:

• Tendon rupture or ligament damage. Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit
• Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit
• Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:
  • hives
  • swollen face
  • breathing trouble
  • chest pain
  • low blood pressure
  • dizziness or fainting
• Fainting. Fainting (passing out) or near fainting can happen in people who receive XIAFLEX, especially following finger procedures
  If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away.
• Increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.

Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure.

The most common side effects with XIAFLEX for the treatment of Dupuytren's contracture include:

• swelling of the injection site or the hand
• bruising or bleeding at the injection site
• pain or tenderness of the injection site or the hand
• swelling of the lymph nodes (glands) in the elbow or armpit
• itching
• breaks in the skin
• redness or warmth of the skin
• pain in the armpit

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist.

Rx Only

Click for full Prescribing Information, including Medication Guide.

About Endo
Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the statements by Dr. Peimer and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" 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, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the research and development and the regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; the proposed business combination transaction between Endo and Mallinckrodt; and the effectiveness of advertising and other promotional campaigns. 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. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A.

*Dupuytren contracture prevalence estimation calculation: average Dupuytren contracture prevalence in the U.S. (5%) multiplied by U.S. population (332 million per 2021 U.S. Census data) = ~17 million.

References:

1. Hurst, LC, Badalamente, MA, et al. New England Journal of Medicine.2009;361(10),968-979.
2. Bayat, A, McGrouther, DA. Annals of the Royal College of Surgeons of England. 2006;88(1),3-8.
3. "How common is Dupuytren disease?" Dupuytren Research Group. April 1, 2017. Accessed January 13, 2025. https://dupuytrens.org/faq
4. "U.S. and world population clock." U.S. Census Bureau. Updated April 13, 2023. Accessed January 13, 2025. https://www.census.gov/popclock 

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SOURCE Endo, Inc.

FAQ

What is the potential market size for NDOI's XIAFLEX treatment for Dupuytren contracture?

The potential market is significant, with an estimated 17 million Americans affected by Dupuytren contracture.

What new data is NDOI presenting at the March 2025 IFSSH Congress?

Phase 4 retrospective study data on XIAFLEX treatment for Dupuytren contracture patients who experienced disease recurrence after surgical correction.

How does NDOI's XIAFLEX treatment differ from traditional Dupuytren contracture therapy?

XIAFLEX offers an alternative to repeat surgery for patients experiencing recurrent deformity after initial surgical treatment.

What medical condition does NDOI's XIAFLEX target?

XIAFLEX targets Dupuytren contracture, a progressive hand condition where collagen cords form under the palm's skin, pulling fingers inward.