- FDA had requested the company remove the drug from the market
- It is a powerful painkiller often abused by addicts
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.”
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.
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.