Endo Pharmaceuticals (ENDP) Wednesday announced that it recently received notification from the U.S. Food and Drug Administration that its new drug application, or NDA, for its new oral formulation of oxymorphone has been granted priority review status.
The new oxymorphone tablet 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.
Endo Pharma said the tablet formulation is designed to resist crushing, breaking, powdering or pulverizing.
The company also said the FDA has set the action date under the Prescription Drug User Fee Act for January 7, 2011.
For comments and feedback: editorial@rttnews.com