FDA Accepts REMOXY New Drug Application and Grants Priority Review

Fox Business, Tuesday, August 12, 2008

SAN MATEO, Calif. and BRISTOL, Tenn., Aug 12, 2008 /PRNewswire-FirstCall via COMTEX/ —-Pain Therapeutics, Inc. and King Pharmaceuticals, 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. More…