DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that data from clinical studies of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting. The meeting is taking place through September 23 in Louisville, Kentucky.
Three presentations cover data from the Phase 1 clinical study of CCH in patients with plantar fibromatosis. Results demonstrated improvement in nodule hardness and in patient and physician satisfaction scores. In addition, the CCH safety profile was consistent with the known CCH safety profile from other clinical studies and indications. Most adverse events were rated as mild to moderate, and there were no reported treatment-related serious adverse events.
A fourth presentation provides real-world treatment patterns derived from a retrospective observational study that compiles a large database of newly diagnosed patients with plantar fibromatosis. These new data address a gap in our knowledge of plantar fibromatosis treatments.
"We're pleased to share information and facilitate a better understanding of plantar fibromatosis in an effort to help improve treatment outcomes," said James P. Tursi, MD, Executive Vice President, Global Research & Development at Endo. "We look forward to presenting our clinical study data as we explore a potential nonsurgical option in patients with plantar fibromatosis."
CCH is not approved for use in treating patients with plantar fibromatosis. Endo has completed a Phase 2 study and anticipates that the pivotal Phase 3 program will begin later this year.
The four presentations are below:
About Plantar Fibromatosis
Plantar fibromatosis (PFI) or Ledderhose disease, sometimes termed "Dupuytren's disease of the foot," is a hyperproliferative fibrous tissue disorder resulting in the formation of nodules along the plantar fascia, the thick connective tissue that supports the arch of the foot, which is often painful. There is no cure for PFI. Symptom management options include custom insoles, topical treatments, over-the-counter pain and anti-inflammatory medications, radiation therapy and steroid injections, and ultimately, surgery may be required to remove the nodules.
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.
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SOURCE Endo International plc