MedinCell’s CEO Christophe Douat states: “We are happy to report that the mdc-CWM program, partnered and in phase 2 clinical trial, is progressing well and on schedule.”
As a reminder, recruitment was capped by MedinCell’s partner at 20 patients for the active phase 2 clinical study in April 2019. All participants have completed their 3-month follow-up visit this summer.
The analysis of the data is being completed by our partner and its subcontracted clinical research organization. 12-month trial completion is scheduled on March 2020. Our partner plans to meet with FDA in the meantime to discuss the current findings and how to progress in the next trial moving forward.
The product is for management of postoperative pain in participants undergoing unilateral total knee replacement. The study’s primary endpoints include pain measures and post-surgical opioid consumption. MedinCell’s CEO Christophe Douat adds: “While total knee replacement surgery leads to decreased pain in most patients, a sizable minority continue to experience severe pain and consume opioids chronically after it. It is one of the surgeries were patients use the most opioids and an estimated 15 % of these, or 150 000 patients per year, become new persistent opioid users for many months after surgery. A decrease in pain and opioid consumption should be viewed as a very positive factor in the current opioid crisis, which is one of the highest priorities of the FDA.”