Pain Therapeutics, King Pharma develop abuse-resistant pain medication
Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. announced they are developing a new abuse-resistant prescription pain medication called PTI-721. Like Remoxy (controlled-release oxycodone), PTI-721's patented formulation is specifically designed to resist common methods of prescription drug abuse or misuse. The active pharmaceutical ingredient in PTI-721 remains undisclosed.
Pain Therapeutics has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for PTI-721 and expects to announce shortly the initiation of a clinical study with this new investigational drug candidate.
Pain Therapeutics and King Pharmaceuticals now have three investigational drug candidates in various phases of clinical and regulatory development. Each drug is intended to address the problem of prescription drug abuse and misuse:
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 misuse and abuse. 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.
In 2005, Pain Therapeutics and King 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 of and worldwide responsibility to exclusively commercialize Remoxy and other abuse-resistant opioid painkillers. Pain Therapeutics retains all development and commercial rights in Australia and New Zealand. 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, PTI-202 and PTI-721, the company has two other drug candidates in clinical programs: Oxytrex and a novel radio-labelled monoclonal antibody to treat metastatic melanoma.
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.