07.05.2009 12:30:00
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King Pharmaceuticals Presents Safety, Efficacy and Measurement Data from Expanded Pain Portfolio
King Pharmaceuticals, Inc. (NYSE: KG) today announced that the Company is presenting study findings from its expanded pain management portfolio at the American Pain Society’s Annual Meeting. Leading researchers are presenting safety and efficacy data for ACUROX® and scientific data confirming validation of innovative measurement standards to evaluate the likeability of opioid analgesics, such as EMBEDA™. King is developing several novel opioid treatment options, including long-acting opioids EMBEDA™ and REMOXY®, and a short-acting opioid, ACUROX®, each of which is uniquely designed to deter misuse and abuse commonly associated with currently approved opioid analgesic products. New Drug Applications for ACUROX®, EMBEDA™ and REMOXY® are all currently under review by the U.S. Food and Drug Administration.
"The variety and magnitude of data being presented at the American Pain Society Annual Meeting demonstrates the commitment King has made to advancing pain management,” said Dr. Eric Carter, Chief Science Officer of King Pharmaceuticals. "We expect to meet the need for effective opioid therapeutic options that also have the potential to reduce the risk of inappropriate or non-therapeutic use through our novel pain treatment product candidates.”
Highlights of King’s presentations and King supported presentations are as follows:
Coordinate Objective and Subjective Clinical Responses to Morphine and Their Attenuation by Naltrexone as a Function of Naltrexone and Morphine Plasma Concentrations – Importance of Using Pupillometry as an Objective Anchor
Pupillary constriction (miosis) is a classic pharmacologic response to opioids, generally within minutes of exposure. This randomized, double-blind, triple dummy crossover study analyzed recreational non-dependent opioid users who were orally administered crushed or whole capsules of ALO-01 (morphine sulfate and naltrexone hydrochloride), morphine solution or placebo. The study examined the relationship between plasma naltrexone and the time-matched miosis. The weakening of the morphine-induced miosis by naltrexone demonstrated that using pupillometry was consistent with the effects on subjective measures of drug-liking and euphoria. These results demonstrate that pupillometry should be used as an objective anchor for studies evaluating the subjective psychopharmacologic effects of opioids.
Study findings featured at APS Data Blitz presentation, May 6, 2009,
Presented by Franklin Johnson, MS
ACUROX® (oxycodone HCl/niacin) Tablets for the Treatment of Acute, Moderate to Severe Pain Following Bunionectomy Surgery in Adult Patients
ACUROX® tablets are a unique composition of short-acting oxycodone HCl, niacin and functional inactive ingredients intended to relieve moderate to severe pain while discouraging common methods of abuse. When the recommended dose of ACUROX® is exceeded, the drug is associated with niacin-induced unpleasant, yet reversible, dysphoric effects. A Phase III study evaluated the analgesic efficacy and safety of ACUROX® in adults with moderate to severe pain following bunionectomy surgery. The 405 participants received either two ACUROX® tablets 7.5/30 mg, two ACUROX® tablets 5/30 mg or two placebo tablets every six hours for 48 hours after surgery. Both doses of ACUROX® tablets demonstrated significant reduction in pain compared to placebo. ACUROX® was generally well tolerated. This is the first study demonstrating the pain relief efficacy and safety of a short-acting opioid composition with ingredients designed to deter excessive oral ingestion.
Poster 236
Estimating Attractiveness of a Not-yet-marketed Opioid Formulation Designed to Deter Common Methods of Abuse (ADF)
As a leader in developing prescription opioid formulations that may deter abuse, King supported a study by Inflexxion, Inc. which sought to estimate how an abuser of prescription opioids might rate the attractiveness of a formulation designed to deter common methods of abuse (ADF) that is not yet on the market. Building on previous work by Inflexxion scientists, in which a scale of abuse attractiveness (OATS) was developed, 32 substance abuse counselors, whose ratings of known products agreed with ratings by prescription opioid abusers, served as proxies for abusers. These proxies rated a not-yet-marketed ADF and four known opioids. The study found that the attractiveness of the not-yet-marketed ADF would be similar to that of a known, unattractive drug and would be significantly different from products that are known to be more attractive for abuse.
Poster 144, being presented by Stephen Butler, Ph.D., Inflexxion
On-Site Details:
Presenters will be at their posters for comment on Friday, May 8 and available for phone interviews upon request.
About EMBEDA™
EMBEDA™ is an investigational long-acting opioid analgesic that 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™ is crushed or chewed, the naltrexone would be released, mitigating the euphoric effect of the morphine. The clinical significance of the degree of these reductions has not been established and there is no evidence that the naltrexone in EMBEDA™ reduces the abuse liability of EMBEDA™.
About ACUROX® Tablets
ACUROX® is an investigational patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate to severe pain. ACUROX® utilizes Acura’s proprietary Aversion® Technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets
About REMOXY®
REMOXY®, an investigational drug, is a unique, controlled-release oxycodone for moderate-to-severe chronic pain. REMOXY® is a high viscosity, liquid formulation in a hard gelatin capsule that is designed to resist common methods of misuse and abuse.
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.
Forward Looking Statement
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 King’s planned presentations; and statements pertaining to the Company’s expectations for its novel pain treatment candidates. 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 King’s ability to conduct its presentations as planned; dependence on the Company’s ability to continue to advance the development of its pipeline products as planned; dependence on the high cost and uncertainty of research, clinical trials, and other development activities involving products in which King has an interest; dependence on the unpredictability of the duration and results of the FDA’s review of Investigational New Drug applications ("IND”), NDAs, and Abbreviated New Drug Applications ("ANDA”) and/or the review of other regulatory agencies worldwide that relate to those projects; 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 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 Form 10-K for the year ended December 31, 2008, 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.
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