Endo International plc (OTC: ENDPQ) announced today that the peer-reviewed Journal of Hand Surgery Global Open published Collagenase Clostridium Histolyticum for the Treatment of Dupuytren Disease: A Delphi-Based Consensus Study.
DUBLIN, Jan. 24, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the peer-reviewed Journal of Hand Surgery Global Open published Collagenase Clostridium Histolyticum for the Treatment of Dupuytren Disease: A Delphi-Based Consensus Study.1 Consensus-based study findings among expert hand surgeons indicate that XIAFLEX® (collagenase clostridium histolyticum) has a wide-ranging application for the appropriate treatment of Dupuytren’s contracture in patients with varying degrees of disease severity and functional impairment. Results from the published research indicate a high level of consensus for using XIAFLEX for the treatment of one- or two-finger metacarpophalangeal (MP) joint contractures, most one- or two-finger proximal interphalangeal (PIP) joint contractures, and most combined MP and PIP joint contractures. “Healthcare providers and patients can choose among multiple surgical and nonsurgical treatment options for Dupuytren’s disease, and without established guidelines, the process for sorting through those choices can be overwhelming,” said Dr. Gary M. Pess, a hand and upper extremity surgeon and lead author of the study. “This study provides insight from experienced hand surgeons about using XIAFLEX to treat varying degrees of Dupuytren’s contracture.” Dupuytren’s disease is a heterogenous fibroproliferative condition of the palmar fascia characterized by the development of fascial nodules and cords that may result in digital contracture affecting hand function.2,3 XIAFLEX is a nonsurgical treatment option for Dupuytren’s contracture when a “cord” can be felt composed of two purified collagenases that work to break down collagen when injected into fibrous tissue.4 About the Report In Round 1, 22 real-world case scenarios were used to determine the panelists’ recommendations for using XIAFLEX to treat metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joint contractures involving a single finger or 2 fingers, with varying degrees of contracture and clinical severity. Each scenario presented a distinct contracture(s) with a series of statements to evaluate the impact of patient- or disease-related features (e.g., age, recurrence, risk of anesthesia, Dupuytren diathesis, poor-quality skin, and post-fasciectomy scarring) on the clinical decision to use XIAFLEX. Researchers captured responses using either yes/no responses or a 5-point Likert scale (“strongly agree,” “agree,” “deficient information,” “disagree,” and “strongly disagree”). Level of agreement for each statement was determined, with a consensus threshold of ≥66.7% for agreement (“strongly agree” and “agree”) or disagreement (“strongly disagree” and “disagree”). Round 2 included statements that did not meet the ≥66.7% threshold for consensus in round 1 and scenarios that explored the “impact of patient decision” (e.g., patient declines open surgical procedure). Statements were rated as described for round 1. Round 3 reassessed the statements that did not reach consensus in round 2 and explored the clinical decision-making process using an open-ended response methodology. Of the 33 hand surgeons who were invited based on their expertise and experience with treatment for Dupuytren’s contracture, 22 agreed to participate in the survey; 20 completed round 1 of the survey, and 19 completed rounds 2 and 3. Overall, 80% had practiced medicine for at least 15 years, and all had completed a fellowship in hand surgery. Ninety percent were board-certified hand surgeons. Consensus-based study findings among expert hand surgeons point to wide-ranging application of XIAFLEX for the treatment of Dupuytren’s contracture for patients with varying degrees of disease severity and functional impairment. 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:
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:
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. Click for full Prescribing Information, including Medication Guide. About Endo Cautionary Note Regarding Forward-Looking Statements Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company’s public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. References
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Company Codes: OTC-BB:ENDPQ, OTC-PINK:ENDPQ |