Endo International said Thursday that it has decided to comply with the FDA's recent request to voluntarily withdraw its opioid pain medication Opana ER (oxymorphone) from the market, even though the company "continues to believe in the [drug's] safety, efficacy and favourable benefit-risk profile." In June, the agency cited data suggesting that abusers of Opana ER, which Endo had reformulated to be crush-resistant, have gone from snorting the drug to injecting it, a shift that potentially contributed to a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy.
Endo stated that neither the FDA's request to pull Opana ER, nor its decision to comply, "reflect a finding that the product is not safe or effective when taken as prescribed." The drugmaker noted that it will work with the regulator to coordinate the orderly withdrawal of Opana ER in order to minimise treatment disruption. As a result of the move, Endo expects to incur an impairment charge of about $20 million for the second quarter of this year, adding the drug had recorded sales of $158.9 million in 2016.
In March, an FDA advisory panel voted 18-8 that the benefits of reformulated Opana ER no longer exceeded its risks. Meanwhile, recently confirmed FDA Commissioner Scott Gottlieb has called for the agency to take more aggressive steps in curtailing opioid abuse. The FDA's request to Endo last month marked the first time it attempted to remove a currently marketed opioid pain drug from sale over the public health consequences of its abuse.
For related analysis, read ViewPoints: The FDA says it's not just about opioids anymore, see also ViewPoints: FDA makes Endo an offer it can't refuse on Opana ER.
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