King Pharmaceuticals achieves milestone: Announces commercial availability of EMBEDA

Sep 21 2009

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).

"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.