Endo International plc said Friday it is withdrawing its supplemental new drug application relating to specific abuse deterrent labeling for Opana, an opioid agonist used to manage severe pain. The company said the decision was made following discussions with the U.S. Food and Drug Administration and that it would continue to analyze data relating to the drug. The company's financial forecasts for 2016 did not assume approval of the application. "We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance OPANA(R) ER," said Sue Hall, Ph.D., executive vice president, chief scientific officer and global head of research & development and quality at Endo. Opana is used for pain that is so severe it requires daily, around-the-clock opoid treatment. Shares rose 4.7% in premarket trade, but are down 62% in the year to date, while the S&P 500 has gained about 7%.
Continue Reading Below
Copyright © 2016 MarketWatch, Inc.