�Pain Therapeutics, Inc. (NASDAQ: PTIE) and King Pharmaceuticals, Inc. (NYSE: KG) today presented the final data set of a antecedently announced pivotal Phase III study of REMOXY�, an investigational drug to treat chronic pain. The last data confirm REMOXY provides effective day-and-night analgesia inside a patented formulation intentional to dissent common methods of misuse and abuse. The Companies believe this Phase III clinical study is the first to show pain pill efficacy of any twice-daily oxycodone preparation over 12 weeks in a turgid, well-controlled clinical study. REMOXY is currently undergoing a priority review by the U. S. Food and Drug Administration (FDA).
The Companies too presented results of a previously unpublished alcohol interaction study. In this study, human volunteers consumed REMOXY 40 mg with up to eight ounces of 80� proof alcohol to simulate the amount of alcohol consumed in a 'binge drinking' session. Results confirm that REMOXY's conceptualization resists dissolution in alcoholic beverage. REMOXY's lack of a 'dose-dumping' effect is intended to keep the quick, powerful euphoric high that is sought by drug abusers.
These data were presented at the twelfth World Congress of the International Association for the Study of Pain (IASP) in Glasgow, Scotland. IASP is a leading professional forum in the sphere of painfulness, consisting of 6,900 professionals involved in the treatment and research of pain.
"For public wellness reasons, we remain implicated about the abuse of prescription drugs and whatever associated addiction, overdose or deaths," aforesaid Nadav Friedmann, PhD, MD, Chief Operating and Medical Officer at Pain Therapeutics. "Our goals are to encourage physicians to treat legitimate chronic pain and to admonish recreational drug abuse. I believe this updated analysis provides farther evidence of the potential difference for REMOXY to attain these goals."
"The results of these studies further substantiate REMOXY's potential as a utile solution that may offer a new standard in chronic painfulness management," aforementioned Dr. Eric Carter, Chief Science Officer of King. "King is committed to developing unambiguously designed medicines, such as REMOXY, that not only meet the needs of chronic nuisance patients only also assist address the problem of prescription dose abuse and misuse, including use with alcohol, which is presently threatening our communities."
About REMOXY
REMOXY, an investigational drug, is a unique, abuse-resistant, controlled-release oxycodone for moderate-to-severe chronic pain. REMOXY's high viscosity, liquid formulation in a hard gelatin capsule is designed to resist plebeian methods of prescription do drugs misuse and abuse. The New Drug Application (NDA) for REMOXY is presently undergoing a priority limited review by the FDA. The FDA is expected to complete its review of the REMOXY NDA in December 2008. If sanctioned, the Companies believe REMOXY could be the first base oxycodone on the grocery that is designed to reduce the risk of misuse and abuse.
Final Results of the REMOXY Phase III Study
412 patients with osteoarthritis participated in this pivotal study. Final data indicate that the REMOXY study achieved a statistically significant issue in its primary terminus, the reduction in pain in the neck intensity wads over the twelve hebdomad treatment period (p = 0.007), and petty endpoints, including Quality of Analgesia (p = 0.004), Global Assessment (p = 0.007), the pain subscale of the WOMAC Osteoarthritis Index (p=0.023) and the physical component of the SF-12 Health Survey (p=0.003). No drug-related safety issues were renowned in this study. As expected, common opioid-related side-effects were observed in treated patients. A copy of the card presentation is available on Pain Therapeutics' web situation at: hypertext transfer protocol://www.paintrials.com/publications.hTML
About the Alcohol Interaction Study
This was a single-center, randomized, four-way crossover study, designed to pass judgment the effects of fermentation alcohol on the rate and extent of absorption of oxycodone from REMOXY. Thirty-seven human volunteers ingested REMOXY 40mg during each of four treatment sequences that were separated by a 96-hour wash period. Study results confirm that REMOXY maintains its controlled-release mechanism when co-administered with 240mL of 4%, 20% or 40% fermentation alcohol. The co-administration of REMOXY with alcohol did not defeat REMOXY's patented controlled-release mechanism, as evidenced by plasma concentration levels. This lack of 'dose-dumping' is intended to prevent the rapid climb up in oxycodone plasma levels and the resulting euphoric high that is sought by recreational drug abusers. A written matter of the poster intro is useable on Pain Therapeutics' web site at http://www.paintrials.com/publications.html
About Chronic Pain
Approximately 50 million Americans suffer from chronic infliction. Chronic infliction can touch an single throughout his or her life, persistent several weeks, months, or even age at a time. The onset of chronic pain may be nociceptive (caused by ongoing tissue injury), neuropathic (caused by equipment casualty to the brain, spinal cord, or peripheral nerves), or disease specific (such as degenerative joint disease or cancer).
Patients with moderate-to-severe chronic pain a great deal require around-the-clock pain rilievo. However, the under-treatment of pain is a major public health issue complicated by the misuse and abuse of prescription opioids. More than 75 gazillion Americans suffer from pain sensation, which is more than the number of people with diabetes, heart disease and crab combined. While there are a number of prescription pain medications available, the increasing misuse, abuse and diversion of prescription painfulness medications, specially among young people, is having an impact on physicians' ability and/or willingness to treat pain and is clogging patient access to these medicines and appropriate care. Additionally, the increasing misapply, abuse and diversion of opioid pain medications pose a dearly-won and significant public health issue. Pain Therapeutics and King are developing novel drugs to address this problem.
About Oxycodone Abuse
Please visit the U.S. Drug Enforcement Administration's site for more information: click here.
About the Alliance Between Pain Therapeutics, Inc. and King Pharmaceuticals, Inc.
In 2005, King and Pain Therapeutics entered into a strategic alliance to develop and commercialize REMOXY and other abuse-resistant opioid painkillers. Pain Therapeutics is substantially responsible for drug formulation, clinical development and regulatory filings for REMOXY and other abuse-resistant opioid painkillers developed under this alliance. Upon regulatory approval, King will assume sole control and worldwide responsibleness to entirely commercialize REMOXY and other abuse-resistant opioid painkillers. Drug candidates developed under this alliance are unique formulations of the patented Oradur� technology licenced from Durect Corporation.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, the Company has three drug candidates in clinical programs, including PTI-202, Oxytrex� and a novel radio-labeled monoclonal antibody to treat metastatic melanoma. Pain Therapeutics is also working on a new discussion for patients with hemophilia. The FDA has non yet evaluated the merits, safety or efficacy of the Company's drug candidates. For more information, please visit hypertext transfer protocol://www.paintrials.com.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical y. King, an S&P 500 Index company, seeks to capitalise on opportunities in the pharmaceutical diligence through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products that complement the Company's focus in specialty-driven markets, peculiarly neuroscience, hospital and sharp care. King strives to be a leader and partner of choice in bringing innovative, clinically-differentiated medicines and technologies to market. http://www.kingpharm.com
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. disclaim whatever intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for innovative statements contained in the Act. Examples of such statements include, but ar not limited to, any statements relating to the whether or when the FDA may approve the NDA for REMOXY; the size and scope of the voltage market for REMOXY and the potential benefits of REMOXY or other of the Companies' drug candidates. Such statements are based on management's current expectations, but literal results may differ materially due to various factors. Such statements involve risks and uncertainties, including, merely not limited to, those risks and uncertainties relating to difficulties or delays in exploitation, testing, regulatory approval, production and marketing of the Companies' drug candidates, unexpected delays in the regulative review of the NDA for REMOXY and unexpected adverse side-effects or inadequate therapeutic efficaciousness of the Companies' drug candidates and other factors that could slow or prevent product approval or market toleration (including the risk that current and past results of clinical trials english hawthorn be found to be insufficient for marketing approving). For farther information regarding these and other risks related to the Companies' business, investors should consult the Companies' respective filings with the U.S. Securities and Exchange Commission.
King Pharmaceuticals, Inc.
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