Endo Pharmaceuticals Inc., a subsidiary of Endo International plc announced that, based on discussions with the U.S. Food and Drug Administration (FDA), the Company has been notified that an Advisory Committee of the FDA will be convened in the fall of 2016 to review the Company's Supplemental New Drug Application (sNDA) for OPANA® ER. As a result of the Advisory Committee meeting, the current Prescription Drug User Fee Act (PDUFA) date of July 29, 2016 for the OPANA® ER sNDA will not be met and the action on the supplement is expected to be taken by the FDA as soon as possible following the Advisory Committee meeting.
"Endo believes in the ability of OPANA® ER to continue making a difference in the lives of appropriate patients," said Sue Hall, Ph.D., Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. "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."
OPANA® ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. The sNDA for OPANA® ER, which is formulated using INTAC® Technology, includes studies designed to evaluate the abuse deterrence of the formulation. INTAC® Technology increases tablet hardness using a high molecular weight polymer (polyethylene oxide).
