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:
- NEW: Treatment patterns for plantar fibromatosis in
the United States: a retrospective
observational study (e-poster presentation)
- Authors: Jill Davis, MS;
Aimee Near, MPH; David Hurley, MD; Laurence Djatche, PharmD, MS;
Jenny Tse, MS; Riddhi P. Doshi, PhD, MBBS, MPH; Elizabeth J. Wang, MS; Luis A. Ortega, MD; David G. Armstrong, MD, PhD, MS
- Participant Satisfaction and Investigator Assessment of
Collagenase Clostridium Histolyticum Injection as a Nonsurgical
Intralesional Treatment Option for Plantar Fibromatosis (podium
presentation)
- Authors: Christopher J.
Anderson, DPM; Richard A.
Pollak, DPM; David Hernandez,
MD; Shannon R. Dalton, PhD;
Qinfang Xiang, PhD; Saji Vijayan, MBBS; Luis
Ortega, MD; Joseph M.
Caporusso, DPM
- Safety Data from a Study of Collagenase Clostridium
Histolyticum Injection in Participants With Plantar Fibromatosis
(poster presentation)
- Authors: Richard A. Pollak, DPM;
David Hernandez, MD; Christopher J. Anderson, DPM; Shannon R. Dalton, PhD; Qinfang Xiang, PhD; Saji
Vijayan, MBBS; Luis Ortega,
MD; Joseph M. Caporusso, DPM
- Collagenase Clostridium Histolyticum Injection in Patients With
Plantar Fibromatosis: A Randomized, Open-Label, Dose-Ranging Study
(e-podium presentation)
- Authors: Christopher J.
Anderson, DPM; Luis Ortega,
MD; Joseph M. Caporusso, DPM;
Richard A. Pollak, DPM; David Hernandez, MD; Shannon R. Dalton, PhD; Qinfang Xiang, PhD; Saji
Vijayan, MBBS
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.
About Endo
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