Current News

Print version | Send article | RSS feed

CeNeS Pharmaceuticals plc files IND for lead product M6G

30 Mar 2007 - CeNeS Pharmaceuticals plc announced the filing of its first Investigational New Drug ("IND") application with the US Food and Drug Administration ("FDA") to commence clinical studies in the US with morphine-6-glucuronide ("M6G"), its novel drug for the treatment of post-operative pain. The opening trial under this IND will be a Phase I pharmacokinetic study in volunteers. This study was required by the FDA as was an additional pre-clinical toxicology analysis. In parallel to conducting these two small studies, CeNeS will complete the protocol design of the first US Phase III trial. CeNeS is actively seeking a partner to collaborate and fund the Phase III US trials.The filing of the IND enhances the package of data already available to potential US partners for review. Neil Clark, Chief Executive of CeNeS, said: "The filing of the IND is a major landmark in the clinical development of M6G. North America is an attractive market for the drug and the filing of the IND demonstrates that CeNeS has the capability to maximise the potential value."
 
Morphine formulations are the gold standard treatment for the relief of moderate to severe post-operative pain. A limitation of morphine treatment is often the unpleasant side effects experienced, of which nausea and vomiting are the most common. PONV is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life. The active potent metabolite of morphine, morphine-6-glucuronide (M6G), may offer therapeutic advantages over morphine in having an equivalent analgesic effect, but with a reduced tendency to cause nausea, vomiting and respiratory depression. Phase II and III clinical trials have shown that M6G given intravenously produces equivalent analgesia to morphine to combat post-operative pain. Studies have also shown that M6G reduced the incidence of nausea and vomiting when compared directly with morphine. Other studies published recently in the scientific literature demonstrate that M6G also reduces respiratory depression compared to morphine.