Endo International has announced that, based on an August 11, 2016 discussion with the FDA, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA ER without prejudice to re-filing. The company plans to continue collecting and analyzing epidemiological data relating to OPANA ER. Endo's financial projections for 2016 did not assume approval of the sNDA.
"We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance OPANA ER," said Sue Hall, Ph.D., executive vice president, chief scientific officer and global head of R&D and Quality at Endo. "We believe in the ability of OPANA ER to continue making a difference in the lives of appropriate patients and remain committed to safely and effectively addressing the 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, included studies designed to evaluate the abuse deterrence of the formulation. INTAC Technology increases tablet hardness using a high molecular weight polymer (polyethylene oxide).