MedinCell announces successful completion of patient enrollment in the Phase 3 study of F14 (mdc-CWM), a first-in-class therapy for localized pain relief after Total Knee Replacement
2023-08-30
临床3期上市批准
Enrolment is complete following the randomization of 151 patients across seven centers in the US
The study was initiated in November 2022 and is proceeding as planned with efficacy results anticipated in Q1 2024
F14 (mdc-CWM) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered intraarticularly at the end of Total Knee Replacement surgery (TKR)
F14 (mdc-CWM) aims to facilitate patient recovery from TKR surgery by providing post-operative pain relief by addressing inflammation, thereby accelerating improvement in knee function, and potentially decreasing the need for addictive opioids
F14 (mdc-CWM) is the third product using MedinCell’s proprietary technology BEPO® to reach, or to have completed, a Phase 3 clinical trial
Download here the complete press release
MONTPELLIER, France--(BUSINESS WIRE)-- MedinCell today announces that its partner, Arthritis Innovation Corporation (AIC), who conducts and finances all development activities of F14 (MedinCell codename: mdc-CWM), has completed the patient enrollment in the first of two Phase 3 clinical studies of F14 in patients undergoing total knee replacement (TKR). F14 (mdc-CWM) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.
About MedinCell
MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™ (BEPO technology is licensed to TevaTeva under the name SteadyTeq™).
We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, MedinCell currently employs more than 140 people representing more than 25 different nationalities.
UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals
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