History with FDA
The FDA originally approved Opana ER 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.”
In 2011, the FDA approved a reformulated version of Opana ER. This new version of the drug was “designed with physicochemical properties intended to make the drug resistant to physical and chemical manipulation for abuse by snorting and injecting.” Although the product did meet all of the regulatory standards for approval, “the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER.”
In 2012, Endo Pharmaceuticals replaced the original formulation of Opana ER with the reformulated product. At the same time, the company petitioned the FDA “to determine that the original Opana ER was withdrawn from market due to safety concerns (which would result in withdrawing generic products referencing original Opana ER from the market).” In 2013, Endo’s petition was denied and the Agency issued a statement regarding its assessment of Opana ER’s reformulation.
FDA’s Recent Request
In March of this year, “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.”
Last week the FDA asked Endo Pharmaceuticals to voluntarily remove the reformulated product from the market. If the company chooses not to remove the product, FDA states that it “intends to take steps to formally require its removal by withdrawing approval.” Additionally, the Agency notes that in the meantime, it is working to ensure that health care professionals as well as other individuals are aware of the serious risks associated with the abuse of the drug.
The FDA’s announcement states that it plans to continue its examination of “the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”
For additional information, view FDA’s press release.