DUBLIN, June 26, 2023 /PRNewswire/ — Endo International plc (OTC: ENDPQ) announced today that the first patient has been enrolled in GRASP-DC (Generating Real-world Ambispective data to Study Participant Treatment outcomes for Dupuytren’s Contracture), a non-interventional registry of up to 1,000 patients with Dupuytren’s contracture (DC). This registry will create the largest and most comprehensive collection of real-world DC data on treatment outcomes.
DC is a progressive hand condition that results in the formation of a collagen rope-like cord that pulls fingers toward the palm and affects an estimated 14 million Americans.
“We’re pleased to support this unprecedented effort to help advance understanding and treatment of Dupuytren’s contracture,” said Gregory Kaufman, M.D., Vice President, Medical Affairs and Chief Medical Officer at Endo. “Along with our study steering committee partners, Endo is committed to supporting the Dupuytren’s patient community.”
“Due to the low diagnosis rate and typically slow progression of Dupuytren’s contracture, the currently available data on the condition is insufficient,” said James Verheyden, M.D., a hand and upper extremity surgeon who enrolled the first patient. “This study will result in the creation of a single registry to facilitate more comprehensive knowledge of treatment and management using real-world evidence.”
The Study is run by a steering committee that consists of Endo, Pulse Infoframe and Drs. Philip Blazar, Gary Pess and James Verheyden.
About the Study
GRASP-DC (NCT05877066) is a non-interventional study of up to 1,000 DC patients from 15 sites who have initiated treatment within two weeks before, at or any time after the date of enrollment. Patients will be followed for up to three years, and data will be collected from both the patients and their healthcare providers.
Patients will answer questions related to, but not limited to, quality of life, reasons for treatment choices, functional outcomes, activities before and after treatment, treatment satisfaction and self-reported treatment effectiveness.
Healthcare providers will answer questions related to, but not limited to, the reason for treatment choice; details of contracture size, location and number of cords treated; active and passive range of motion before and after treatment; and treatment techniques used.
About Dupuytren’s Contracture
DC 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 DC progresses, it may become difficult for individuals to use their hand(s) for daily tasks and activities.
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.
About Pulse Infoframe
Pulse Infoframe is a real-world evidence generation, health informatics, and insights company that has built a structured technology and services platform designed to extract, curate, analyze, and disseminate evidence-based conclusions that improve the quality of people’s lives. Pulse Infoframe provides a full solution for registries, natural history studies, and other observational and regulatory grade studies. With provider relationships for patient access, Pulse Infoframe ensures that insights, evidence, and publication results are disseminated across the ecosystem, including advocacy organizations, key opinion leaders, researchers, and sponsors. Learn more at www.pulseinfoframe.com. 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 statements by Drs. Kaufman and Verheyden, any statements relating to product efficacy, clinical trials or studies, 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 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 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; any actual or contingent liabilities; settlement discussions or negotiations; the Company’s liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company’s businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company’s chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company’s businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company’s businesses; the unpredictability of the Company’s financial results; the Company’s ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company’s indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company’s ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward- looking statements, except as required to do so by law.
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SOURCE Endo International plc
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