Endo withdraws Opana ER sNDA, but will continue data collection

Ireland-incorporated Endo International (Nasdaq: ENDP) said today that, based on an August 11, 2016 discussion with the US Food and Drug Administration, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for its opioid antagonist 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. The company’s shares gained 2.4% to $23.55 in premarket trading.

"We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance Opana ER," said Sue Hall, 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," Dr Hall added.