Endo Pharmaceuticals Pulls Opioid From Market After FDA Request
Endo Pharmaceuticals has removed an opiate from the market after requests by the FDA.
Friday, the FDA asked that Opana ER be taken off the market after what they call careful consideration.
The agency says the request was based on its concern that the benefits of the drug may no longer outweigh its risks.
This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.
The FDA’s review focused on all available postmarketing data, which they say demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the drug’s reformulation.
Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder.
Opana ER 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.
In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.
While the product met 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.
Now, with more information about the risks of the reformulated product, Opana ER was removed from the market.