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
30 Agosto 2023 - 02:26PM
Business Wire
- 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
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 Teva 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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David Heuzé - Head of Communications
david.heuze@medincell.com / +33 (0)6 83 25 21 86
Investors Relations France Louis-Victor
Delouvrier/Alban Dufumier medincell@newcap.eu / +33 (0)1 44 71
94 94
Media Relations Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94
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