Regulators have tacked on an additional three months of review time for subcutaneous methylnaltrexone--being developed by Wyeth and Progenics--so it can take more time to review safety data on the drug. Regulators want new data on the opioid-induced constipation drug's affect on QT prolongation, where the heart cannot pump blood throughout the entire body. Researchers for the companies say there is no evidence of a QT prolongation effect.
"We, along with our collaborator, Wyeth, are confident in our subcutaneous methylnaltrexone submission," says Paul J. Maddon, M.D., Ph.D, Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "We are enthusiastic about the entire methylnaltrexone program and plan to submit an NDA for the intravenous formulation of methylnaltrexone for the management of post-operative ileus later this year."
- here's the release