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Endo to withdraw FDA application for abuse-deterrent labelling on opioid drug

pharmafile | August 15, 2016 | News story | Sales and Marketing Endo, Endo International, abuse deterrent, opioid 

Endo International has announced that, following discussions with the US Food and Drug Administration (FDA), it has decided to withdraw its supplemental new drug application for specific deterrent labelling for the opioid painkiller, Opana ER.

It has been an uncertain few months for the Dublin-based company, with shares falling almost 40% after the company cut its financial year outlook in May, but the shares have rallied since then.

The FDA has previously indicated, as part of action plan on opioids, to prioritise abuse deterrent drugs and make them widely available in an attempt to reverse the opioid epidemic. While they have not indicated what exactly made them withdraw the application, they have indicated that they will go back to the FDA with more data to support this claim in the future.

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Sue Hall, chief scientific officer at Endo, says: “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.”

Sean Murray

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