Endo International just took its extended-release opioid painkiller Opana ER (otherwise known as oxymorphone hydrochloride) off the market.
The move comes almost a month after the Food and Drug Administration asked that the drug be removed when it found that the drug’s benefits no longer outweighed its risk for abuse.
“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 Scott Gottlieb said in a news release at the time.
“Endo International plc continues to believe in the safety, efficacy, and favourable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse,” the company said in a news release. “Nevertheless, after careful consideration and consultation with the FDA following the FDA’s June 2017 withdrawal request, the Company has decided to voluntarily remove Opana ER from the market.”
The company said it expects a $US20 million impairment charge in the second quarter of 2017.
More than 183,000 people died from overdoses related to prescription opioid painkillers like oxycodone, hydrocodone, fentanyl, and morphine over the last 15+ years.
Endo’s stock was down more than 2% on Thursday.