Opana ER (oxymorphone hydrochloride extended-release tablets) was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
The product, currently marketed by Endo Pharmaceuticals, is a reformulation of the original product, designed with physicochemical properties intended to make the drug resistant to physical and chemical manipulation for abuse by snorting and injecting. While the reformulation was approved in 2011, the FDA determined that the drug did not meet the agency’s standards for being considered abuse-deterrent and therefore declined Endo’s request to include a description of abuse-deterrent properties in product labeling.
Endo replaced the original formulation of Opana ER with the new formulation in 2012, and petitioned the agency to determine that the original Opana ER was withdrawn from market due to safety concerns (which would result in withdrawing generic products referencing original Opana ER from the market). The FDA denied that petition and issued a statement in 2013 regarding our assessment of the reformulation of Opana ER.
On March 13-14, 2017, an independent FDA advisory committee met to discuss the abuse patterns and other safety concerns related to Opana ER and voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.
In June 2017, the FDA requested that Endo Pharmaceuticals remove reformulated Opana ER from the market because the benefits no longer outweigh the risks.
Following the FDA’s request, Endo announced in July 2017 that it would voluntarily remove reformulated Opana ER from the market.