Endo Pharmaceuticals Inc. recently announced that the U.S. Food and Drug Administration (FDA) has informed the company that an Advisory Committee will be meeting on its supplemental new drug application for OPANA ER.
OPANA ER is a opioid agonist that helps in the management of severe pain that requires consistent treatment. The company states the medication features its INTAC technology. The company states that the tablet was able to be hardened by utilizing a high molecular weight polymer. A portion of the supplement to the new drug application was to address study data regarding abuse deterrence formulation.
"Endo believes in the ability of OPANA® ER to continue making a difference in the lives of appropriate patients," EVP, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo Sue Hall said. "Endo has been a long standing leader in treating pain and we are working to advance new options to safely and effectively address the unique needs of the pain patient community."
The FDA committee meeting will be taking place in the fall of this year. For this application the Prescription Drug User Fee Act date that had been set for July 29 would not be met due to the committee meeting. Action on the supplemental application will be made at following the meeting.