CENES REPORTS POSITIVE RESULTS FROM POSTOPERATIVE PAIN STUDY

CeNeS Pharmaceuticals has announced preliminary results from a pivotal Phase III trial of morphine-6-glucuronide (M6G) in more than 500 patients with postoperative pain.

The randomized, double-blind study was conducted at 24 centers in six European countries. The study was designed primarily to provide key information on a comparison of effective intravenous pain management regimens of M6G with morphine treatment for a minimum of 24 hours and up to 48 hours following major abdominal surgery.

The trial results show unequivocally that M6G is as good as morphine in terms of analgesia achieved in patients up to 48 hours after an operation, according to the company. Successful achievement of this primary endpoint supports data from previous clinical trials of M6G.

The study also confirmed the potential of M6G as an analgesic with a clinically significant improved side-effect profile compared with morphine. Patients receiving M6G experienced a 28 percent reduction in the severity of postoperative nausea and vomiting in the key period of six to 24 hours after treatment.

In addition, the trial showed that M6G's safety profile is similar to that of morphine. Aside from nausea and vomiting, the adverse events reported were at levels similar to those experienced by patients receiving morphine in a postoperative setting.

"M6G has the potential to be a significant new medicine with a unique profile that will assist patients and physicians alike in the successful management of postoperative pain," Neil Clark, chief executive of CeNeS, said. "CeNeS is confident that it has a substantial data package that differentiates M6G from morphine which will be attractive to a larger pharma partner to license. CeNeS intends to file an investigational new drug application for M6G with the FDA in the next few weeks."