For the first time, the Food and Drug Administration (FDA) is seeking to ban a previously approved opioid due to its addictive qualities. In this decision, the FDA specifically recognized the public health risk of the opioid epidemic and committed to making other similar evaluations with other drugs.
FDA Aims to Ban Opana ER
On June 8, 2017, in an unprecedented move, the FDA requested Endo Pharmaceuticals take one of their opioid pain medications—reformulated Opana ER (oxymorphone hydrochloride)—off the market because of its extreme abuse risk. The FDA rendered this decision, following its advisory panel vote in March of 18-8, based on an updated risk-benefit analysis of the drug.
The FDA explained in a statement: “After careful consideration, the agency is seeking removal 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.”
“My comment is ‘wow,'” according to Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. “This is pretty exciting. This is big news.”
Opana ER was originally approved in 2006 to manage long-term, round-the-clock, moderate to severe pain. Unfortunately, many people began to abuse the drug—achieving a quick, intense high by crushing, then snorting or injecting it. In fact, the drug is approximately two times more potent than OxyContin, which is also frequently abused.
In response to the abuse, Endo replaced the formula for Opana ER in 2012, seeking a label that described “abuse deterrent properties” from the FDA. The FDA approved the new version of the drug, but denied the new labeling because there was insufficient evidence to
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