King Pharmaceuticals gets FDA approval for Embeda

BRISTOL, Tenn. The Food and Drug Administration has approved a prescription painkiller designed to thwart drug diversion.

King Pharmaceuticals announced Thursday the approval of Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, calling it the first FDA-approved, long-acting opioid designed to reduce narcotic effects when tampered with by crushing or chewing.

“Today’s approval of Embeda marks a milestone in pain care, and King is proud to bring this new technology to the U.S. market,” King CEO Brian Markison said in a statement. “King is committed to providing resources and medicines to patients and healthcare professionals to achieve optimal pain control.”

The capsules contain morphine pellets with naltrexone hydrochloride in the middle. When taken as directed, the morphine relieves pain, and the naltrexone hydrochloride passes through the body. If crushed or chewed, however, the naltrexone is released and neutralizes the morphine. King hopes the technology will discourage illegal drug users, though it said there was no evidence that naltrexone reduces the probability that Embeda will be abused, and the clinical significance of its ability to neutralize morphine had not been established.

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