BRISTOL, Tenn., Aug. 13 /PRNewswire-FirstCall/ -- King Pharmaceuticals((R)), Inc. (NYSE: KG) today announced that the U.S. Food and Drug Administration (FDA) has approved EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, 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. EMBEDA(TM) is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.
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"Today's approval of EMBEDA(TM) marks a milestone in pain care, and King is proud to bring this new technology to the U.S. market," said Brian A. Markison, Chairman, President, and Chief Executive Officer of King. "King is committed to providing resources and medicines to patients and healthcare professionals to achieve optimal pain control. We are focused on developing medicines that use novel technologies designed to reduce drug liking and make it more difficult to extract the active ingredient. We anticipate a September 2009 launch for EMBEDA(TM)."
Utilizing King's proprietary technology, EMBEDA(TM) contains extended-release morphine pellets, each with an inner core of naltrexone hydrochloride, an opioid receptor antagonist. If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect. If EMBEDA(TM) is crushed or chewed, the naltrexone is released and absorbed with the morphine, reversing the morphine's subjective and analgesic effects. The clinical significance of the degree of this reduction has not been established, and there is no evidence that the naltrexone in EMBEDA(TM) reduces the abuse liability of EMBEDA(TM).
"The development of formulations like EMBEDA(TM) that employ technologies designed to reduce drug liking and euphoria associated with non-medical uses could potentially change how chronic pain is treated. Prescribers and patients have been hoping and waiting for safer medicines to treat chronic pain," said Nathaniel Katz, M.D., M.S., President of Analgesic Research and Adjunct Assistant Professor, Tufts University.
Markison added, "In addition to EMBEDA(TM), King is developing a portfolio of long- and short-acting opioid pain medications and technologies that are designed to offer treatment while reducing potential risks of unintended uses. We believe that we could be well positioned to treat a wide range of patients with products designed to address this important societal issue."
An estimated 50 million Americans live with chronic pain, a serious, undertreated public health problem. Opioids provide effective pain management and are especially useful in treating appropriately selected patients with moderate to severe chronic pain who have not responded adequately to other pain management therapies.
Clinical Trial Data to Support EMBEDA(TM)
The FDA approval was based on data from 12 clinical studies of EMBEDA(TM), including phase III data demonstrating efficacy and safety. In a phase III study, EMBEDA(TM) provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared with placebo. Additionally, an earlier phase II study found EMBEDA(TM) was bioequivalent to another marketed extended-release morphine sulfate capsule product.
Phase III findings also showed that EMBEDA(TM) was safe and well tolerated in patients treated for up to 12 months, with an overall safety profile consistent with the most common opioid-related adverse events.
