Health & Fitness
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Fri, January 30, 2009 King Pharmaceuticals Announces Positive Results from a 12-Month Open-Label Safety and Efficacy Study of EMBEDA" Extended Releas
BRISTOL, Tenn.--([ BUSINESS WIRE ])--King Pharmaceuticals, Inc. (NYSE:KG) today reportedresults from its Phase III 12-month open-label safety and efficacy study evaluating EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules. The results were presented in a poster session (abstract #229) at the American Academy of Pain Medicine's 25th Annual Meeting in Honolulu, HI. The results showed that EMBEDA™ provided continued pain relief for up to 12 months in opioid-tolerant patients with chronic, moderate to severe, non-malignant pain. Findings also showed that EMBEDA™ was safe and well-tolerated for long-term chronic pain therapy.
EMBEDA™ is a long-acting Schedule II opioid analgesic that King is developing in response to the need for opioid analgesics that have the potential to reduce the risk of misuse and abuse. Utilizing King's proprietary technology, EMBEDA™ contains extended-release morphine pellets, each with a sequestered core of naltrexone, an opioid antagonist. The formulation is designed to work such that if taken as directed, the morphine would relieve pain while the sequestered naltrexone would pass through the body with no intended clinical effect. If EMBEDA™ pellets are chewed or crushed, naltrexone is released and rapidly absorbed, reducing the feeling of drug liking and euphoria. This means EMBEDA™ may reduce misuse or abuse when tampered with by crushing or chewing.
The secondary efficacy findings from the study demonstrated that patients who were taking EMBEDA™ reported significant decreases in pain, as measured by the weekly Brief Pain Inventory (BPI) Average Pain Intensity Score from the start of the study to the 52-week endpoint. Additionally, 90 percent of evaluable patients assessed EMBEDA™ as good, very good or excellent from baseline to endpoint.
"This clinical study showed that EMBEDA™ continued to effectively decrease pain over a period of 12 months in chronic pain patients," said Dr. Eric Carter, Chief Science Officer of King Pharmaceuticals. "These results, along with earlier safety and efficacy findings, demonstrate that EMBEDA™ has the potential to be one of the first formulations designed to deter common methods of misuse and abuse, while safely and effectively treating patients with chronic pain."
The EMBEDA™ New Drug Application (NDA) was submitted in June 2008 and is currently under review by the U.S. Food and Drug Administration (FDA).
An estimated 50 million Americans live with chronic pain1, 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.2,3A However, the misuse, abuse and diversion of prescription opioids has escalated along with increased legitimate use in pain management.4,5A,6 In fact, 70 percent of people who have abused opioids obtained the drugs from friends and relatives (by stealing, buying, or accepting them).7 As a result of the increasing misuse, abuse and diversion of prescription medicines, especially among young adults, patients and physicians may be reluctant to initiate opioid therapy for pain relief.5B Therefore, there is a need for products that deliver effective pain relief while minimizing the potential for misuse, abuse and diversion.3B,8
Study Design
The 52-week, multi-center study consisted of a 12-month treatment phase to measure the safety and efficacy of EMBEDA™ in patients with chronic, moderate to severe, non-malignant pain. Of the 467 enrolled patients, 160 completed the study and were treated with dosages of EMBEDA™ that were based on each patient's previous treatment. Patient dosages were adjusted throughout the study, using the patients' most painful joint or body area to serve as the target for pain relief. Study participants were allowed to use acetaminophen as needed as a rescue medication, up to 500 mg every six hours, and aspirin to help prevent potential cardiovascular-related side effects of opioid use.
Efficacy assessments included pain intensity scores on the BPI, patient global assessment of the drug and daily dose of rescue medication, which were reported for patients remaining in the study at each visit.
Primary safety findings from the study were reported previously and demonstrated that EMBEDA™ was generally safe and well-tolerated during long-term therapy of up to 12 months. The adverse events largely occurred during the first month of treatment during the titration to effective EMBEDA™ dose, and remained stable for the duration of the study. The most common adverse events were those typically associated with opioid use: constipation (31.8 percent), nausea (25.2 percent), headache (12 percent) and vomiting (11.8 percent).
About EMBEDA™
EMBEDA™ is an Investigational New Drug currently under review by the FDA and has a proposed indication 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™ is an extended-release form of morphine intended for once or twice daily dosing.
About King Pharmaceuticals, 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 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 potential benefits of EMBEDA™ Capsules if approved. 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 unpredictability of the duration and results of the FDA's review of the EMBEDA™ NDA. 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 Form 10-K for the year ended December 31, 2007 and Form 10-Q for the quarter ended September 30, 2008, which are on file with the U.S. Securities and Exchange Commission ("SEC"). 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.
References
1. Treatment Options: A Guide for People Living in Pain. Baltimore, MD: American Pain Foundation; 2006.
2. Katz NP, Adams EH, Chilcoat H, et al. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007; 23:648-660.
3. Woolf CJ, Hashmi M. Use and abuse of opioid analgesics: potential methods to prevent and deter non-medical consumption of prescription opioids. Curr Opin Invest Drugs. 2004; 5:61-66.
4. Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007; 297:249-251.
5. Gagnon AM, Kahan M, Srivastava A. Opioid use and abuse: is there a problem? Clin J Pain. 2007; 23:661-662.
6. Birnbaum HG, Whiate AG, Reynolds JL, et al. Estimated costs of prescription opioid analgesic abuse in the United States in 2001: a societal perspective. Clin J Pain. 2006; 22:667-676.
7. Substance Abuse and Mental Health Services Administration. (2007). Results from the 2006 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-32, DHHS Publication No. SMA 07-4293). Rockville, MD.
8. Wright C, Kramer ED, Zalman MA, et al. Risk identification, risk assessment, and risk management of abusable drug formulations. Drug Alcohol Depend. 2006; 83(Supp 1):S68-S76.
