Under pressure from the FDA, Endo has decided to pull from the market its opioid painkiller Opana ER, a drug that generated nearly $160 million in sales last year.
The Dublin-based drugmaker said that while it still believes in the safety and effectiveness of the drug, and has done its best to fight its abuse, it will voluntarily comply with the FDA’s removal request.
Endo will take a $20 million charge in the second quarter on the remaining value of the drug. It said it has realized about $35.7 million in sales of Opana ER in the first quarter, after reporting $158.9 million in 2016. Endo shares were off more than 2.10% after the announcement.
“Endo plans to work with FDA to coordinate the orderly removal of Opana ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals,” the company said in a statement.
The move comes a month after the FDA asked the drugmaker to halt sales, saying that in the midst of an opioid addiction crisis, the risks of Opana ER outweigh its benefits. While it said Endo could chose not to comply, it warned that it would take steps to require removal from the market if Endo didn’t.
It was the first time the FDA has asked for removal of an opioid and follows the recommendation of an advisory committee that in March voted 18 to 8 that the drug's risks were greater than its benefits, a contention refuted by the drugmaker. While the drug was formulated to deter its abuse, addicts were said to have found ways to foil that technology.
This was one of the first policy decisions by the agency since Scott Gottlieb was appointed FDA commissioner by President Trump. In his campaign, Trump talked about the devastation of the opioid addiction crisis that resulted in about 33,000 overdose deaths in 2015.
In making the request, the agency also warned drugmakers last month that it intended to weigh the risk-benefit profiles of all approved opioid analgesic products “and take further actions as appropriate as a part of our response to this public health crisis.”
Opioid makers also are defending themselves against a cascade of lawsuits, many by states that have high rates of death due to opioid overdose. Most claim the drugmakers oversold the benefits and downplayed the risks in their marketing of the drugs to the public and doctors.