Endo Pulls Opana sNDA After Meeting with FDA

Endo International says that after meeting with FDA 8/11 it has decided to withdraw its supplemental NDA seeking specific abuse deterrent labeling for Opana ER (oxymorphone HCl extended-release tablets). The sNDA covered a formulation using the company’s INTAC Technology and included studies designed to evaluate the formulation’s abuse deterrence. INTAC is designed to increase tablet hardness using a high molecular weight polymer (polyethylene oxide).The company plans to continue collecting and analyzing epidemiological data related to the drug product in hopes of resubmitting in the future. “We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance Opana ER,” it says. The opioid agonist is indicated for managing pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate.