Sep. 21, 2009 (PR Newswire) -- BRISTOL, Tenn., Sept. 21 /PRNewswire-FirstCall/ -- King Pharmaceuticals(R), Inc. (NYSE: KG) today announced a true milestone as it marks the first commercial availability for EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 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. King has begun shipments of six dosage strengths (20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg and 100 mg/4 mg) and is instituting a wholesale and retail stocking program to disseminate this product to retail pharmacies across the U.S. EMBEDA(TM) is the first U.S. Food and Drug Administration (FDA)-approved long-acting opioid designed to reduce drug liking and euphoria when tampered with by crushing or chewing. However, the clinical significance of the degree of reduction in drug liking and euphoria reported in clinical studies has not yet been established. There is no evidence that the naltrexone in EMBEDA(TM) reduces the abuse liability of EMBEDA(TM).

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"Combining the efficacy of morphine with a sequestered opioid antagonist is a novel approach to treating pain," explained Dr. Eric Carter, King's Chief Science Officer. EMBEDA(TM) contains extended-release morphine pellets, each with an inner core of naltrexone hydrochloride (HCl), an opioid receptor antagonist. If tampered with by crushing or chewing, the naltrexone HCl is released and absorbed with the morphine. Naltrexone reverses the subjective and analgesic effects of morphine 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 manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing EMBEDA(TM) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

EMBEDA(TM) contains pellets of an extended-release oral formulation of morphine sulfate, an opioid receptor agonist, surrounding an inner core of naltrexone hydrochloride, an opioid receptor antagonist indicated 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(TM) is NOT intended for use as a prn analgesic.

EMBEDA(TM) 100 mg/4 mg IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. Ingestion of these capsules or the pellets within the capsules may cause fatal respiratory depression when administered to patients not already tolerant to high doses of opioids.

Patients should not consume alcoholic beverages while on EMBEDA(TM) therapy. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on EMBEDA(TM) therapy. The co-ingestion of alcohol with EMBEDA(TM) may result in an increase of plasma levels and potentially fatal overdose of morphine. EMBEDA(TM) is to be swallowed whole or the contents of the capsules sprinkled on apple sauce. 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.

Crushing, chewing, or dissolving EMBEDA(TM) will also result in the release of naltrexone which may precipitate withdrawal in opioid-tolerant individuals.

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    --  EMBEDA(TM) is contraindicated in patients with a known hypersensitivity
to morphine, morphine salts, naltrexone, or in any situation where
opioids are contraindicated
--  EMBEDA(TM) is contraindicated in patients with significant respiratory
depression in unmonitored settings or the absence of resuscitative
equipment
--  EMBEDA(TM) is contraindicated in patients with acute or severe bronchial
asthma or hypercapnia in unmonitored settings or the absence of
resuscitative equipment
--  EMBEDA(TM) is contraindicated in any patient who has or is suspected of
having paralytic ileus
--  EMBEDA(TM) may be expected to have additive effects when used in
conjunction with alcohol, other opioids, or illicit drugs that cause
central nervous system depression because respiratory depression,
hypotension, and profound sedation or coma may result
--  Respiratory depression is the chief hazard of all morphine preparations
such as EMBEDA(TM).