BioWorld International Correspondent

LONDON - CeNeS Pharmaceuticals plc announced positive results in the final analysis of a European Phase III trial of its morphine metabolite M6G in the treatment of post-operative pain, and said it is completing plans for the final Phase III trial, which will start in the next quarter.

Following that, the Cambridge, UK-based company said it would file for approval in 2006 with European launch expected in 2007.

In the 168-patient trial, a single intravenous administration of M6G resulted in a statistically significant reduction of morphine administration by patient-controlled analgesia at 12 and 24 hours following knee-replacement surgery under spinal nerve block.

The study also showed a dose-response relationship, with a decrease in morphine consumption as the dose of M6G increased.

While showing M6G has equivalent analgesic power to morphine, the trial also provided some evidence of a superior side effect profile, with lower incidence of nausea and vomiting. However, as all patients used some morphine, it was not possible to do a detailed analysis of the effects of M6G in reducing such side effects.

That will be assessed in the final Phase III study, which will be powered to show both non-inferiority of analgesic effects, superior side effect profile and efficacy in a broad range of surgical procedures. In October, CeNeS, which is listed on the Alternative Investment Market, raised £11.4 million (US$21.4 million) in a placing and open offer to pay for the trial. Neil Clark, CEO, said, "CeNeS has sufficient funds to deliver the second Phase III in Europe and is well placed to capitalize on the product opportunity."