The FDA said Thursday it has requested that Endo Pharmaceuticals voluntarily withdraw its reformulated opioid pain medication Opana ER (oxymorphone) from the market, saying that "after careful consideration, [the agency is concerned] that the benefits of the drug may no longer outweigh its risks." The FDA noted this is the first time it has taken steps to remove a currently marketed opioid pain drug from sale due to the public health consequences of its abuse. Endo's shares were down as much as 14 percent on the news.
Recently appointed FDA commissioner Scott Gottlieb said the US is facing "a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse." He added "we will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population, but also in regard to its potential for misuse and abuse."
The agency said its decision was based on a review of post-marketing data following the 2012 launch of a reformulated version of Opana ER that was designed to be crush-resistant. According to the FDA, the data "demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection," and the injection abuse has been linked to a serious outbreak of HIV and hepatitis C, as well as cases thrombotic microangiopathy.
In March, an FDA advisory panel voted 18 to 8 that the benefits of reformulated Opana ER no longer exceeded its risks. The agency stated that it plans to take steps to formally require Opana ER to be removed from the market if Endo refuses to comply with its request for voluntary withdrawal.
In response to the news, Endo said it "is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward." Sales of Opana ER totalled $158.9 million in 2016, representing about 4 percent of Endo's revenue. In August last year, the drugmaker withdrew its application seeking specific abuse-deterrent labelling for the therapy following discussions with the FDA.
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