Endo Withdraws Opana ER sNDA in Order to Get More Data on Abuse Deterrence
Endo announced that the Food and Drug Administration (FDA) has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for Opana ER (oxymorphone) without prejudice to re-filing.
Opana ER, an opioid agonist, is indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. It utilizes INTAC Technology that increases tablet hardness using polyethylene oxide, a high molecular weight polymer. The sNDA included studies evaluating the abuse deterrence of the formulation.
Endo will keep collecting and analyzing epidemiological data regarding Opana ER. They anticipate compiling more data and working with the FDA to move forward.
Opana ER is available as 5mg, 7.5mg, 10mg, 15mg, 20mg, 30mg, and 40mg extended-release tablets.
For more information call (800) 462-3636 or visit Opana.com.