US FDA approves King's Embeda as abuse-resistant painkiller
This article was originally published in Scrip
Executive Summary
The US FDA has approved King Pharmaceuticals' Embeda Extended Release Capsules (morphine sulphate and naltrexone hydrochloride), a product specifically designed to prevent abuse, for moderate to severe chronic pain. The approval comes seven months after the drug's original user fee date, but bodes well for a class of abuse-resistant pain pills that have faced regulatory difficulties.