FDA review of King's Embeda likely to extend into "early 2009"

King Pharmaceuticals says that the US Food and Drug Administration is continuing its review of the New Drug Application for Embeda (morphine  sulfate and naltrexone HCl) extended-release capsules. It is likely that  this review will extend into early 2009.

"Our discussions with the FDA continue to progress and we remain  confident in the strength of our regulatory submission," said Eric  Carter, chief science officer of King.

Utilizing King's proprietary technology, Embeda capsules contain  extended-release morphine pellets, each with a sequestered core of  naltrexone, an opioid antagonist. The formulation is designed to work so  that if taken as directed, the morphine would relieve pain while the  sequestered naltrexone would pass through the body with no observed  clinical effect. If the capsules are crushed or chewed, the naltrexone  would be released, mitigating the euphoric effect of the morphine.