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King Announces Commercial Availability of EMBEDA(TM)
Date:9/21/2009

e by competitively binding to opioid receptors. Opioid antagonists are commonly used to reverse the effects of opioids in overdose emergencies and for the treatment of alcohol dependence.

Will Rowe, CEO of the American Pain Foundation, stated, "Effective pain management begins by removing barriers and helping patients manage their pain. When used responsibly and monitored regularly, these new technologies may help ease concerns prescribers may have when recommending current standard-of-care opioid treatments-allowing more pain patients to get the care they need."

In order to ensure that the benefits of EMBEDA(TM) outweigh the potential risks of EMBEDA(TM), King has implemented a Risk Evaluation and Mitigation Strategy (REMS) in response to a requirement of the FDA. The goals of this REMS are to inform patients and providers about the potential for abuse, misuse, overdose, and addiction of EMBEDA(TM) and about the safe use of EMBEDA(TM). The REMS program for EMBEDA(TM) also provides education on additional areas including, but not limited to, individualizing dosage, proper patient selection, and warnings and precautions. Side effect profiles should be considered when prescribing EMBEDA(TM), as they are similar to other opioid analgesics. EMBEDA(TM) is meant to be swallowed whole or opened and the contents of the capsules sprinkled on applesauce. The pellets in the capsules are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of morphine.

Important Safety Information: Black Box Warning

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WARNING: EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules contain morphine, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid agonists. EMBEDA(TM) can be abused in a manne
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SOURCE King Pharmaceuticals, Inc.
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