FDA advisory panel to review Remoxy and Embeda
Executive Summary
FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees will review two abuse-resistant formulations of opioids for chronic pain Nov. 13 and 14: Pain Therapeutics/King Pharmaceuticals' Remoxy XRT (oxycodone hydrochloride controlled-release) and Alpharma Pharmaceuticals' Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride). Risk management plans could play a large role in the votes, as indicated by the fate of Cephalon's analgesic Fentora (buccal fentanyl), earlier this year (1"The Pink Sheet" DAILY, Sept. 15, 2008)