Max
08-12-2008, 07:26 PM
FDA Accepts REMOXY New Drug Application and Grants Priority Review
Last update: 8:03 a.m. EDT Aug. 12, 2008
SAN MATEO, Calif. and BRISTOL, Tenn., Aug 12, 2008 (PrimeNewswire via COMTEX) -- Pain Therapeutics, Inc. (
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).
http://www.marketwatch.com/news/story/fda-accepts-remoxy-new-drug/story.aspx?guid={A474F712-EEE2-4314-8DB4-25DE50B22C0E}&dist=hppr
Last update: 8:03 a.m. EDT Aug. 12, 2008
SAN MATEO, Calif. and BRISTOL, Tenn., Aug 12, 2008 (PrimeNewswire via COMTEX) -- Pain Therapeutics, Inc. (
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).
http://www.marketwatch.com/news/story/fda-accepts-remoxy-new-drug/story.aspx?guid={A474F712-EEE2-4314-8DB4-25DE50B22C0E}&dist=hppr