Endo withdraws supplemental NDA for OPANA

Endo International has decided to withdraw its supplemental new drug application relating to specific abuse deterrent labelling for opioid antagonist OPANA ER without prejudice to re-filing.

The decision was made based on discussions on Thursday with the US Food and Drug Administration and Endo noted that its financial forecasts for 2016 did not assume approval of the application.

The company said it intends to continue collecting and analysing epidemiological data relating to the opioid antagonist, which is indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which there are no adequate alternative treatments.

Chief scientific officer and global head of research and development and quality, Sue Hall, said: “We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance OPANA ER.

"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."

Endo shares were up 4.7% in pre-market trade to $24.10.