Excess Oral Doses of Acurox Tablets are Disliked by Subjects with a History of Opioid Abuse
Study Evaluating the Abuse Liability of Acurox® Tablets Highlighted at the American Society of Addiction Medicine's (ASAM) 40th Annual Medical-Scientific Conference
NEW ORLEANS--(BUSINESS WIRE)--May 1, 2009 - King Pharmaceuticals, Inc. (NYSE: KG) and Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today presented the results from an oral abuse liability study of Acurox® (oxycodone HCl/niacin) Tablets, AP-ADF-111 (Study 111), at the American Society of Addiction Medicine's (ASAM) Medical-Scientific Conference. The results of Study 111 demonstrate that Acurox® Tablets are disliked among people with a history of opioid abuse compared to oxycodone HC1 tablets alone, when excess doses are swallowed. Dr. Donald R. Jasinski, Chief of the Center for Chemical Dependence of Johns Hopkins Bayview Medical Center, authored the study.
“The fact that people with a history of opioid abuse showed a disliking of the Acurox® Tablets in excessive doses is an indication that the product is an important step in the development of medicines that are designed to deter common methods of abuse, such as over ingestion, while effectively managing pain,” said Dr. Jasinksi. “The ASAM Meeting provides a premier forum for King and Acura to share insights with addiction specialists and hear feedback that can lead to further advances in pain medication treatments.”
King and Acura are jointly developing Acurox® Tablets whose New Drug Application has been granted a priority review classification by The U.S. Food and Drug Administration (FDA). The companies expect a response from the FDA by June 30, 2009.
Study 111 - A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Oxycodone HC1/Niacin Tablets (Acurox® Tablets) in Subjects with a History of Opioid Abuse
Acurox® Tablets contain a unique composition of oxycodone HCl, niacin, and essential functional inactive ingredients, and are intended to relieve moderate-to-severe pain while deterring common methods of prescription drug abuse including intentionally swallowing excess quantities of tablets, crushing and snorting tablets, and dissolving tablets for injection. Niacin is well tolerated at the recommended two-tablet dose, however, as doses are escalated, niacin induces increasingly unpleasant, dysphoric, yet temporary, effects.
To assess the effect of oxycodone HCl on the niacin-induced effects of Acurox®, 30 subjects with a history of opioid abuse were administered 240 mg of niacin alone, Acurox® at four times the recommended 5mg/30mg tablet dose (40mg/240mg), and placebo, in randomized, crossover fashion (Sequence 1). To assess the abuse liability of Acurox® versus oxycodone HCl alone, the subjects were administered Acurox® at four times the recommended dose and oxycodone HCl 40mg alone in randomized, crossover fashion (Sequence 2).
The primary efficacy measure of abuse deterrence potential in Study 111 was determined using a 29-point visual analogue scale (Drug Rating Questionnaire-Subject) which assessed the subjects' like/dislike of a drug's effects. In Sequence 1, results demonstrated with statistical significance (p=0.03) that niacin 240mg was disliked compared to placebo, and oxycodone HCl 40mg had limited effect on niacin-induced disliking. In Sequence 2, it was demonstrated with clinically meaningful and statistically significant results (p=.033) that administration of excessive numbers of Acurox® Tablets equivalent to 40mg of oxycodone HCl (i.e., four times the intended 2 tablet dose) was aversive at 30 minutes compared to oxycodone HCl 40mg alone.
About Prescription Drug Abuse
The undertreatment of pain is a major public health issue complicated by abuse of prescription opioids. More than 75 million Americans suffer from pain, which is more than the number of people with diabetes, heart disease and cancer combined. While there are a number of effective prescription pain medications available, the increasing misuse, abuse and diversion of prescription pain medications – especially among young adults – is having a major impact on physicians' ability and/or willingness to treat pain and is impeding patient access to medicines and care. According to the National Institute on Drug Abuse, nearly 10 percent of high school seniors have abused Vicodin®, a commonly used short acting opioid pain medicine. The increasing misuse, abuse and diversion of opioid pain medications have become widespread and pose a costly and significant public health issue in and of itself. In 2005, the estimated total cost associated with opioid abuse, including health care, justice, and work-related costs, totaled $9.5 billion. The pain relief medicines that Acura is developing with King are designed to address this problem.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of innovative Aversion® (abuse deterrent) Technology and related product candidates. Acura entered into a License, Development and Commercialization Agreement with King Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned subsidiary of King Pharmaceuticals, Inc., in October 2007 pursuant to which Acura and King are now jointly developing Acurox® Tablets and three additional opioid analgesic product candidates utilizing Aversion® Technology.
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, manufacturing and marketing of pharmaceutical products for food producing animals.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). When used in this press release, the words "estimate," "project," "anticipate," "expect," "intend," "believe," and similar expressions are intended to identify forward-looking statements. Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. disclaim any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risk factors include, but are not limited to, our ability to gain FDA approval of the Acurox® Tablets NDA, the FDA's responding to our NDA for Acurox® by June 30, 2009, the Companies' ability to gain FDA approval of product labeling for the proposed indication or the abuse deterrent features and benefits of Acurox®, and the market acceptance and sales potential for Acurox® Tablets. You are encouraged to review these and other risks and uncertainties detailed in each company's respective 2008 Form 10-K filed with the Securities and Exchange Commission.
Contact: King Pharmaceuticals, Inc.
David E. Robinson, 423-989-7045
Vice President, Investor Relations
Lauren Harris, 202-955-6222
Peter A. Clemens, CFO, 847-705-7709
Posted: May 2009