CeNeS files IND with US FDA for M6G

Cambridge, UK-based CeNeS Pharmaceuticals has filed its first Investigational New Drug application with the US Food and Drug Administration to commence clinical studies in the USA 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 healthy volunteers, which was required by the FDA as was an additional preclinical 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.

"The ongoing analysis of the Phase III results further confirms our belief in the excellent potential of M6G as a novel product for post-operative pain. The quality and breadth of the data contained in this large study supports M6G's anticipated product profile," the firm said.