The FINANCIAL — King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (NASDAQ: PTIE) on December 27 announced that King has resubmitted a New Drug Application (NDA) for REMOXY (oxycodone) to the U.S. 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 (NASDAQ: DRRX) 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.
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