Health News and Scoops

King Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. EMBEDA is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.

Utilizing King’s proprietary technology, EMBEDA contains extended-release morphine pellets, each with an inner core of naltrexone hydrochloride, an opioid receptor antagonist. If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect. If EMBEDA is crushed or chewed, the naltrexone is released and absorbed with the morphine, reversing the morphine’s subjective and analgesic effects. The clinical significance of the degree of this reduction has not been established, and there is no evidence that the naltrexone in EMBEDA reduces the abuse liability of EMBEDA.

Press

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