Endo Withdraws Its SNDA for OPANA, Stock Up

Endo International plc

disclosed that it decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA® ER. It also pledged not to refile. The move comes on the heels of a discussion with the FDA on an August 11. The Company indicated that it would continue collecting and analyzing epidemiological data relating to OPANA ER. Endo clarified that its financial estimate for the current year did not include the FDA's approval of the sNDA. Endo's EVP and Chief Scientific Officer, 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." Following this, the stock moved up by $1.09, or 4.74 percent, in the pre-market trading on Friday.