FDA Approves Harder-to-Abuse Painkiller Embeda

painkillersKing Pharmaceuticals announced that the painkiller Embeda has been approved by the U.S. Food and Drug Administration for the management of moderate to severe chronic pain. Embeda is an extended-release opioid drug that is designed to be more difficult for patients to abuse.

Patients can induce euphoria by tampering with opioid tablets, either by crushing or chewing them. Embeda consists of an extended-release morphine capsule with an inner core of naltrexone hydrochloride, an opioid antagonist that prevents the body from responding to the drug. The naltrexone core simply passes through the body if Embeda is taken as directed. But if the patient crushes or chews the capsule, the naltrexone escapes and reverses the effects of the morphine.

The FDA approval was based on 12 studies of Embeda, including a Phase III clinical trial in which Embeda was shown to significantly reduce osteoarthritis pain compared to a placebo. Another study found that Embeda reduced patient liking and euphoria among recreational drug users. The approval is good news for the Bristol, Tenn.-based company, which lost two patents on its bestselling muscle relaxant Skelaxin in January.

Competitors in the opioid painkiller arena include PainCeptor Pharma Corporation, Grunenthal, Adolor Corporation, and Progenics Pharmaceuticals.

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