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Pain Therapeutics and King Pharmaceuticals, today announced that the New Drug Application (NDA) for REMOXY(r) was accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA)
SAN MATEO, CA. and BRISTOL, TN, USA | August 12, 2008 | Pain Therapeutics, Inc. (Nasdaq:PTIE) and King Pharmaceuticals, Inc. (NYSE:KG) today announced that the New Drug Application (NDA) for REMOXY(r) was accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA). The FDA typically grants Priority Review to drug candidates that have the potential to demonstrate significant improvements compared to marketed products. The FDA goal for completing review of a drug with Priority Review status is six months from the date the application was submitted. The REMOXY NDA was submitted to the FDA on June 10, 2008.
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. 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.
Abuse of controlled-release oxycodone is a serious health concern. Abusers easily defeat the controlled-release mechanism by crushing or dissolving oxycodone tablets in alcohol. Ingesting a broken tablet results in 'dose-dumping', which produces a quick, powerful euphoric high that can be fatal or lead to dependence or addiction. The development of abuse-resistant opioid medications remains a major, but elusive, public health goal.
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: http://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(tm) 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(tm) 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.
SOURCE: Pain Therapeutics, Inc. |
