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.