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. The most common adverse events reported in the EMBEDA(TM) clinical program were consistent with the well-known adverse reactions associated with morphine, including constipation, nausea, and somnolence.
The data also showed that sequestered naltrexone hydrochloride did not compromise the safety and efficacy of the morphine. In a separate study of recreational drugs users, EMBEDA(TM), when crushed and taken orally, was shown to have reduced drug liking and euphoria compared with an equivalent dose of immediate-release morphine sulfate solution. The clinical significance of the degree of reduction in drug liking and euphoria reported in these studies has not yet been established. There is no evidence that the naltrexone in EMBEDA(TM) reduces the abuse liability of EMBEDA(TM).
EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules is a long-acting Schedule II opioid analgesic that is 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 an extended-release form of morphine intended for once- or twice-daily dosing. Because EMBEDA(TM) is an extended-release product; it should not be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine. EMBEDA(TM) is NOT intended for use as a prn analgesic, and it is not indicated for postoperative use.
Important Safety Information for EMBEDA(TM)
EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules is a prescription medicine used to treat moderate to severe pain that continues around the clock and is expected to last for a long period of time. EMBEDA(TM) is not for use to treat pain as needed. EMBEDA(TM) contains morphine a Schedule II controlled substance. Morphine is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. EMBEDA(TM) contains beadlike pellets that are made up of morphine sulfate, an opioid receptor agonist (narcotic pain medicine), and naltrexone hydrochloride (HCl), an opioid receptor antagonist. The naltrexone hydrochloride within each pellet is confined or sequestered and has a special coating to protect it from being released. EMBEDA(TM) is to be swallowed whole or the contents of the capsules sprinkled on apple sauce. Do not crush, dissolve, or chew EMBEDA(TM) or the pellets in the capsules. If tampered with by crushing or chewing, the naltrexone will be released.
Like other opioids, EMBEDA(TM) is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment and in patients who have or are suspected to have paralytic ileus. Respiratory depression is the primary risk of opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients.
EMBEDA(TM) may not be right for patients who have trouble breathing or lung problems, a head injury or brain problem, liver or kidney problems, convulsions or seizures, problems urinating or prostate problems, and patients who have or have had drug abuse or drug addiction problems. Patients should be advised that EMBEDA(TM) may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal neonatal physical dependence, and neonatal withdrawal may occur.
Individualization of dosage is essential to make optimal use of this medication. The highest dose of EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) is for "opioid tolerant" patients only. Patients should not consume alcoholic beverages or use prescription or non-prescription medications containing alcohol while on EMBEDA(TM) therapy.
The most common side effects of EMBEDA(TM) are constipation, nausea, and sleepiness. These are not all the possible side effects of EMBEDA(TM). To see the EMBEDA(TM) full prescribing information and Medication Guide go to www.EMBEDA.com or www.KingPharm.com.
About King Pharmaceuticals((R)), Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company's focus in specialty-driven markets, particularly neuroscience and hospital. King's wholly owned subsidiary, Alpharma Inc., is also a leader in the development, registration, manufacture, and marketing of pharmaceutical products for food-producing animals.
About Forward-Looking Statements
This release contains forward-looking statements which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the development of products designed to reduce drug liking and euphoria associated with 'non-medical' uses and the potential effects of these products upon pain treatment techniques; the potential timing of the commercial launch of EMBEDA(TM); and the potential attributes or benefits of products in development. These forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include dependence on the future level of demand for and net sales of King's products; dependence on King's ability to successfully market its products; dependence on the availability and cost of raw materials; dependence on no material interruptions in supply by contract manufacturers of King's products; dependence on the potential effect on sales of the Company's existing products as a result of the potential development and approval of a generic substitute for any such product or other new competitive products; dependence on the potential effect of future acquisitions and other transactions pursuant to the Company's growth strategy; dependence on King's compliance with FDA and other government regulations that relate to the Company's business; dependence on changes in general economic and business conditions; changes in current pricing levels; changes in federal and state laws and regulations; changes in competition; unexpected changes in technologies and technological advances; and manufacturing capacity constraints. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Annual Report on Form 10-K for the year ended December 31, 2008, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, each of which is on file with the U.S. Securities and Exchange Commission. King does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.
EMBEDA is a trademark of Alpharma Pharmaceuticals LLC, a wholly owned subsidiary of King Pharmaceuticals((R)), Inc.
Copyright (C) 2009 King Pharmaceuticals((R)), Inc. All rights reserved.
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