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.
