ACUROX(R) and EMBEDA (TM) Data Highlighted at the College on Problems of Drug Dependence Annual Meeting
RENO, Nev., June 25 /PRNewswire/ -- King Pharmaceuticals, Inc. (NYSE: KG) today announced that the Company is presenting safety and efficacy data for ACUROX(R) and EMBEDA(TM) (ALO-01), two novel opioid analgesic formulations that are in development, at the 71st Annual Meeting of the College on Problems of Drug Dependence. King is also developing other pain medicines employing unique technology platforms designed to address risks associated with currently marketed opioids.
"We anticipate that ACUROX(R) and EMBEDA(TM), upon approval, will offer new therapeutic tools for physicians treating people living with pain," said Eric Carter, Chief Science Officer of King Pharmaceuticals. "Our expectation is that these novel technologies could become instrumental in a physician's arsenal of safe and effective pain medicines that can help with an overall risk management plan."
Highlights of King's presentations and King supported presentations are as follows:
ACUROX(R) (oxycodone HCl/niacin) Tablets for the Treatment of Acute, Moderate to Severe Pain Following Bunionectomy Surgery in Adult Patients
ACUROX(R) Tablets are a unique composition of short-acting oxycodone HCl, niacin and functional inactive ingredients intended to relieve moderate to severe pain. A Phase III study evaluated the analgesic efficacy and safety of ACUROX(R) in adults with moderate to severe pain following bunionectomy surgery. The 405 participants received either two ACUROX(R) Tablets 7.5/30 mg, two ACUROX(R) Tablets 5/30 mg or two placebo tablets every six hours for 48 hours after surgery. Both doses of ACUROX(R) Tablets demonstrated significant reduction in pain compared to placebo. The adverse event profile was similar to that seen with short-acting oxycodone, and ACUROX(R) was generally well tolerated.
Evaluation of Plasma Naltrexone Concentrations Resulting From Use of ALO-01 (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules for Chronic Pain
EMBEDA(TM) Capsules (ALO-01), a novel opioid formulation, contain pellets of an extended-release formulation of morphine sulfate surrounding an inner core of naltrexone hydrochloride. EMBEDA(TM) is intended to treat moderate to severe chronic pain. This 12 month open-label safety study evaluated the plasma concentrations of naltrexone following use of ALO-01 (morphine sulfate and naltrexone hydrochloride). Samples were drawn to measure plasma concentrations (concs) of morphine (M) naltrexone (N) and its metabolite, 6-beta-naltrexol (6-beta-N) when taken as directed. Results showed that, when ALO-01 was taken as directed, steady state plasma morphine levels remain stable. Naltrexone and 6-beta-N do not accumulate; small amounts, when detected, were not dose related and not associated with clinically observable effects of opioid withdrawal or reduction of pain relief.
Phase II Study to Evaluate the Dose Response for Flushing, Safety and Tolerability of Escalating Doses of Niacin in Fasted and Fed Healthy Adult Volunteers
ACUROX(R) Tablets, with Aversion(R) Technology, are a composition of oxycodone HCl, niacin, and other inactive ingredients. The niacin ingredient can generate a temporary, but increasingly unpleasant effect, including flushing. A Phase II study was conducted to evaluate the dose response for niacin-induced flushing, the effect of food on niacin-induced flushing, and the safety and tolerability of varying doses of niacin. Volunteers were broken into two groups (fed and fasted) and were provided varying doses of niacin to consume over a period of days. Results demonstrated a niacin dose-response relationship in both fed and fasted volunteers, with niacin being better tolerated in the fed state. Also, the most frequently reported adverse effects (AEs) were those commonly associated with niacin. These findings suggest that niacin will be well tolerated up to 60 mg per dose and will likely be well tolerated at 90 mg per dose.
Phase II Multiple-Dose Study of the Safety and Tolerability of Niacin 30 mg and 60 mg Combined With Oxycodone HCl 5 mg Versus Oxycodone HCl 5 mg Alone in Healthy Adult Volunteers
A Phase II study was conducted to evaluate the safety and tolerability of multiple daily doses of the active components of ACUROX(R) Tablets, and to determine if tolerance to the effects of niacin develops after repeat administration. Three groups of participants received different doses of niacin combined with oxycodone HCl, and the Side Effects and Symptoms Questionnaire (SESQ) and the Niacin Tolerability Rating Scale (TRS) were used to assess niacin tolerability end points. Results showed that approximately 75 percent of all volunteers in all groups rated the tolerability of study drugs as easy to tolerate or as having no effect, and that adverse effects (AEs) were consistent with the known safety profiles of oxycodone and niacin. These findings support the safety and tolerability of niacin in ACUROX(R) Tablets when taken at the recommended dose.
The Interaction Between Opioids and Alcohol: Results from a Global Literature Review
The potential risk for alcohol to interact with drugs and/or disrupt a drug formulation matrix is a prevalent safety concern. For extended-release opioids, there is an added concern that ethanol (EtOH) may disrupt the formulation mechanism leading to increased bioavailability of the opioid. Although the combination of EtOH and prescription opioids is frequently cited as having increased impairing effects, very few studies have examined the extent of the pharmacokinetic (PK) and pharmacodynamic (PD) interaction between them, particularly when taken at therapeutic doses. A literature review was conducted to gather published data on the safety risks associated with alcohol-opioid interactions, alcohol-induced dose-dumping, and the methodology used to characterize such interactions. The review found that the combination of EtOH and select opioids at the studied doses does not appear to produce additive pharmacodynamic effects, while the pharmacokinetic profiles may be affected for certain other opioids when combined with EtOH. Additional studies would be required to further assess and verify these findings
About ACUROX(R) Tablets
ACUROX(R) 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(R) utilizes Acura's proprietary Aversion(R) Technology. Aversion(R) Technology is a patented triple-action composition of niacin and inactive ingredients. These ingredients can generate a temporary, unpleasant effect if orally over-consumed, turn dissolved tablets into a thick gelatinous mixture making it difficult to draw into a syringe, or produce a mild burning sensation in the nostrils when crushed and snorted. There is no evidence that ACUROX(R)'s triple-action combination of niacin and inactive ingredients reduces its abuse liability.
EMBEDA(TM) 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(TM) 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(TM) reduces the abuse liability of EMBEDA(TM).
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's wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacture and marketing of pharmaceutical products for food producing animals.
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 King's planned presentations; statements pertaining to the Company's expectations for its novel pain treatment candidates and potential prospective physician utilization of these candidates; and statements pertaining to the Company's expectations regarding the FDA's review of the Company's NDAs for Acurox(R) (oxycodone hydrochloride and niacin) tablets and Embeda(TM). 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 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 March 31, 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.
|SOURCE King Pharmaceuticals, Inc.|
Copyright©2009 PR Newswire.
All rights reserved