King Pharmaceuticals resubmits NDA for REMOXY

Dec 28 2010

King Pharmaceuticals®, Inc. and Pain Therapeutics®, Inc. today 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 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.