Endo International, a Dublin, Ireland-based specialty pharmaceutical company, has withdrawn its supplemental new drug application (sNDA) for Opana ER (oxymorphone hydrochloride extended-release) without prejudice to re-filing, based on a discussion with the US Food and Drug Administration (FDA) on August 11. The sNDA was related to specific abuse-deterrent labeling for the drug. Endo plans to continue collecting and analyzing epidemiological data relating to Opana ER.

Opana ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate.The company plans to generate additional data and will seek a collaboration with the FDA to appropriately advance the drug. The sNDA for Opana ER, which is formulated using the company’s Intac technology, included studies designed to evaluate the abuse deterrence of the formulation. Intac technology increases tablet hardness using a high molecular weight polymer (polyethylene oxide).

Source: Endo International