FDA Asked a Drug-maker to Remove Opioid Painkiller from Market
US regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it.
The US Food and Drug Administration has asked Endo Pharmaceuticals (NASDAQ:ENDP) to stop selling its reformulated, extended-release painkiller, Opana ER, after concluding the drugs’s risks outweigh its benefits.
It’s the 1st time the FDA has asked a drug-maker to remove an opioid painkiller from the market. The agency said it has seen a “significant shift” from people crushing and snorting Opana ER to get high to injecting it.
Endo said in a statement it’s “reviewing the request and is evaluating the full range of potential options.”
Wall Street responded with a sell-off, and Endo shares dove 13.4% to 11.11 in trading after US markets closed.
The FDA move comes after advisers, reviewing the safety of Opana ER at a March hearing, voted 18-8 against keeping it on the market.
Besides contributing to overdoses, abuse of Opana ER was blamed for a Y 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles, according to the FDA.
“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits.”
About 2-M Americans are addicted to Rx opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin.
If Endo does not comply with the FDA’s request to stop selling Opana ER, the agency can hold a hearing and start a formal process for rescinding its approval.
According to the FDA, there are no generic versions of the reformulated Opana ER on the market. However, generic versions of both the original Opana ER and the original immediate-release version, called oxymorphone ER, are on sale.
Endo Pharmaceuticals makes generic pills and specialty drugs, which generally are expensive medicines for complex disorders. It’s part of Endo International plc, which is based in Dublin, Ireland.
Endo had about $4-B in revenue last year, $159-M of that from Opana.
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