Endo Announces FDA Advisory Committee Meeting For OPANA ER

(RTTNews) - Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (ENDP, ENL.TO), announced that, based on discussions with the U.S. Food and Drug Administration, 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 or sNDA for OPANA ER.

As a result of the Advisory Committee meeting, the current Prescription Drug User Fee Act or 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.

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).