Endo Pharma to withdraw application for new opioid painkiller formulation
Endo Pharmaceuticals PLC has decided to withdraw its supplemental new drug application for the extended-release version of its Opana opiod painkiller but said it would continue to work with the U.S. Food and Drug Administration to advance the drug.
Shares in the company ENDP, -2.03% added 2.4% to $23.55 in premarket trading.
The pharmaceutical company, which is domiciled in Dublin and has U.S. headquarters in Malvern, Pa. plans to continue collecting and analyzing data on the drug and could refile.
“We anticipate the generation of additional data, and we will seek collaboration with FDA to appropriately advance Opana ER,” said Dr. Sue Hall, global head of research and development and quality at Endo.
Opana ER, one of Endo’s biggest selling brand-name drugs, has been facing generic competition. During the first quarter, sales of Opana ER declined 4.7% to $44.7 million and comprised roughly 14% of Endo’s U.S. branded drug revenue and a third of sales in its pain-management segment.
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