FDA extends review of King Pharmaceuticals’s Embeda extended release capsules

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 such that if taken as directed, the morphine would relieve pain while the sequestered naltrexone would pass through the body with no observed clinical effect, the company said.

If Embeda capsules are crushed or chewed, the naltrexone would be released, mitigating the euphoric effect of the morphine.

Eric Carter, chief science officer of King Pharmaceuticals, said: “Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission. We look forward to working closely with the agency as needed throughout the review process.”