GLASGOW, Scotland--(BUSINESS WIRE)--Pain Therapeutics, Inc. (NASDAQ: PTIE) and King Pharmaceuticals, Inc. (NYSE: KG) today presented the final data set of a previously announced pivotal Phase III study of REMOXY®, an investigational drug to treat chronic pain. The final data confirm REMOXY provides effective around-the-clock analgesia within a patented formulation designed to resist common methods of misuse and abuse. The Companies believe this Phase III clinical study is the first to show analgesic efficacy of any twice-daily oxycodone formulation over 12 weeks in a large, well-controlled clinical study. REMOXY is currently undergoing a priority review by the U. S. Food and Drug Administration (FDA).
The Companies also presented results of a previously unpublished alcohol interaction study.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 formulation resists dissolution in alcohol. REMOXY’s lack of a ‘dose-dumping’ effect is intended to prevent the quick, powerful euphoric high that is sought by drug abusers.
These data were presented at the 12th World Congress of the International Association for the Study of Pain (IASP) in Glasgow, Scotland. IASP is a leading professional forum in the field of pain, consisting of 6,900 professionals involved in the treatment and research of pain.
“For public health reasons, we remain concerned about the abuse of prescription drugs and any associated addiction, overdose or deaths,” said 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 discourage recreational drug abuse. I believe this updated analysis provides further evidence of the potential for REMOXY to achieve these goals.”
“The results of these studies further substantiate REMOXY’s potential as a useful solution that may offer a new standard in chronic pain management,” said Dr. Eric Carter, Chief Science Officer of King. “King is committed to developing uniquely designed medicines, such as REMOXY, that not only meet the needs of chronic pain patients but also help address the problem of prescription drug abuse and misuse, including use with alcohol, which is currently 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 common methods of prescription drug misuse and abuse. The New Drug Application (NDA) for REMOXY is currently undergoing a priority review by the FDA. The FDA is expected to complete its review of the REMOXY NDA in December 2008. If approved, the Companies believe REMOXY could be the first oxycodone on the market 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 result in its primary endpoint, the decrease in pain intensity scores over the twelve week treatment period (p = 0.007), and secondary 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 noted in this study. As expected, common opioid-related side-effects were observed in treated patients. A copy of the poster presentation is available on Pain Therapeutics’ web site at: http://www.paintrials.com/publications.html
About the Alcohol Interaction Study
This was a single-center, randomized, four-way crossover study, designed to evaluate the effects of ethanol 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 washout period. Study results confirm that REMOXY maintains its controlled-release mechanism when co-administered with 240mL of 4%, 20% or 40% ethanol. 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 rise in oxycodone plasma levels and the resulting euphoric high that is sought by recreational drug abusers. A copy of the poster presentation is available on Pain Therapeutics’ web site at http://www.paintrials.com/publications.html
About Chronic Pain
Approximately 50 million Americans suffer from chronic pain. Chronic pain can affect an individual throughout his or her life, lasting several weeks, months, or even years at a time. The onset of chronic pain may be nociceptive (caused by ongoing tissue injury), neuropathic (caused by damage to the brain, spinal cord, or peripheral nerves), or disease specific (such as osteoarthritis or cancer).
Patients with moderate-to-severe chronic pain often require around-the-clock pain relief. However, the under-treatment of pain is a major public health issue complicated by the misuse and 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 prescription pain medications available, the increasing misuse, abuse and diversion of prescription pain medications, especially among young people, is having an impact on physicians’ ability and/or willingness to treat pain and is impeding patient access to these medicines and appropriate care. Additionally, the increasing misuse, abuse and diversion of opioid pain medications pose a costly 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 website for more information: www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycodone.htm
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 responsibility to exclusively commercialize REMOXY and other abuse-resistant opioid painkillers. Drug candidates developed under this alliance are unique formulations of the patented Oradur™ technology licensed 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 treatment for patients with hemophilia. The FDA has not yet evaluated the merits, safety or efficacy of the Company’s drug candidates. For more information, please visit www.paintrials.com.
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 that complement the Company’s focus in specialty-driven markets, particularly neuroscience, hospital and acute care. King strives to be a leader and partner of choice in bringing innovative, clinically-differentiated medicines and technologies to market.
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 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. Examples of such statements include, but are 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 potential 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 actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Companies’ drug candidates, unexpected delays in the regulatory review of the NDA for REMOXY and unexpected adverse side-effects or inadequate therapeutic efficacy of the Companies’ drug candidates and other factors that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials may be found to be insufficient for marketing approval). For further 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.
Contacts
Pain Therapeutics, Inc. Christi Waarich, 650-645-1924 Senior Manager of Investor Relations or King Pharmaceuticals, Inc. James E. Green, 423-989-8125 Executive Vice President, Corporate Affairs
