FDA grants priority review status for Endo’s oxymorphone oral formulation

Endo PharmaceuticalsSep 23 2010

Endo Pharmaceuticals (Nasdaq: ENDP) announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that Endo's new drug application (NDA) for its new oral formulation of long-acting oxymorphone, which is designed to be crush resistant, has been granted priority review status.  The FDA has set the action date under the Prescription Drug User Fee Act (PDUFA) for Jan. 7, 2011.

This new oxymorphone formulation is a semi-synthetic opioid analgesic intended for the treatment of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. It is a tablet formulation designed to resist crushing, breaking, powdering or pulverizing.