One month after the FDA asked it to remove an opioid from the market, pharmaceutical maker Endo has announced it will pull the drug.
The company said in a statement posted on its website it still believes in the efficacy and safety of Opana ER, or oxymorphone hydrochloride.
The FDA said the request was the first time it had asked that an opioid pain medication be pulled because of “the public health consequences of abuse.”
Opana ER is a powerful painkiller, about twice as powerful as OxyContin, another often abused opioid.
Endo said it had worked for years to “combat misuse and abuse.” The drug was approved in 2006 and was intended to be used to manage moderate to severe pain over a long period with just one pill.
But addicts crushed it to get a massive high all at once
So, the company made the tablets with a coating that made them hard to crush. It also changed the formula in 2012.
The FDA said post-market data suggested that after the company reformulated the medication, people were injecting it more than they were snorting it.
If Opana ER sounds familiar, it’s because it was the drug of choice for many addicts at the center of an HIV outbreak in Indiana in 2015.
The company will work with the FDA on a timeline to remove the drug from the market while giving patients and doctors the chance to find new treatments.
Endo sold $35.7 million worth of Opana ER in the first three months of 2017 and $158.9 million last year.
The United States is in the midst of an opioid overdose epidemic, according to the US Centers for Disease Control and Prevention. Opioid overdose killed more than 33,000 people in 2015, more than any year on record. Nearly half of all overdose deaths involve some kind of prescription drug.