CeNeS nears end of recruitment in M6G trial

Cambridge, UK-based CeNeS Pharmaceuticals, a specialist in the field of pain control, sedation and other central nervous system disorders, says that it has nearly completed recruitment in a Phase III study of M6G, its lead product for the treatment of post-operative pain. The firm added that it has successfully overcome country-specific issues relating to the distribution of M6G and morphine, both of which are controlled drugs.

The double-blind trial is designed to compare the efficacy of M6G as part of an intravenous pain management regimen with that of morphine, which is considered the gold standard. Specifically, the program will asses the relief conferred by both drugs following major abdominal surgery. The level of nausea caused by either agent will also be monitored.

Additionally, in July this year CeNeS held a pre-investigational new drug meeting with the US Food and Drug Administration's Analgesia, Anethesia and Rheumatology Division, during which the FDA accepted that M6G is ready to enter Phase III assessment, subject to the completion of a small preclinical fertility study and a pharmacokinetic trial. The firm said that it is confident that it, or a partner, will be able to start Phase III trials in 2007.