King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. announced that King has resubmitted a New Drug Application (NDA) for Remoxy (oxycodone) to the US Food and Drug Administration (FDA) in response to a Complete Response letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.

Remoxy is a twice daily, long–acting formulation of oral oxycodone for moderate to severe pain requiring continuous, around–the–clock opioid treatment for an extended period of time. Remoxy was developed by Pain Therapeutics, using Durect Corporation’s Oradur technology, to help address the growing problem of non–medical use of prescription opioids. Remoxy is comprised of a high–viscosity, liquid formulation in a hard gelatin capsule that is designed to provide steady, around–the–clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone.

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 and technologies that complement the company’s focus in specialty–driven markets, particularly neuroscience and hospital.

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to Remoxy, the company has three other drug candidates in clinical programmes. These include a novel monoclonal antibody–based treatment against metastatic melanoma.