Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. announced that the New Drug Application (NDA) for Remoxy was accepted and granted Priority Review by the US 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.
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.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. In addition to Remoxy, the Company has three drug candidates in clinical programmes, including PTI-202, Oxytrex and a novel radio-labeled monoclonal antibody to treat metastatic melanoma.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company.