FDA ruling on opioid painkiller deals blow to Endo

Drug maker 'extremely disappointed' by agency's decision

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

The FDA responded to a petition filed by Endo, a subsidiary of Endo Health Solutions, saying that an earlier version of the drug Opana ER (oxymorphone hydrochloride) was not withdrawn from the market due to reasons of safety and effectiveness because, unlike the newer version, it did not include abuse-deterrent features. The agency said that while the newer version of Opana ER can resist crushing better than the older version, it is still susceptible to abuse by cutting, grinding or chewing, and various methods would still allow its abuse through injection or snorting.

In December 2012, the U.S. District Court for the District of Columbia dismissed a case that Endo filed against the FDA, alleging that the agency had failed to fulfill an obligation to determine whether the original version of Opana ER was withdrawn for safety reasons, clearing the way for Impax Labs' January 2013 launch of the generic.

The abuse-deterrent version of the drug was launched in early 2012, and in February, when Endo announced its fourth quarter 2012 earnings, the company said the new version had reduced the abuse rate by 59%.

Malvern, Pa.-based Endo said it was "extremely disappointed" with the decision. The company said the launch of generic versions of Opana ER would reduce the branded version of the drug's sales by up to $120 million this year. The drug had sales of $299.3 million in 2012, down 22% from 2011's $384.3 million, according to Endo.

"With the approval and expected launch of additional non-abuse deterrent generic versions of Opana ER, we will carefully assess Endo's position in the competitive landscape and explore all options, including those intended to mitigate the effect of this decision," Endo president and CEO Rajiv De Silva said. "Endo remains committed to patient safety, including appropriate use of our products, as a top priority."

Meanwhile, the FDA reached a different conclusion with regard to generic versions of another commonly abused opioid painkiller, Purdue Pharma's OxyContin (oxycodone). In April, the agency said it would not approve any generic version of OxyContin that did not include the abuse-deterrent features of the branded version.


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