The maker of opioid painkiller Opana ER is pulling the drug off the market at the request of federal regulators because it’s being abused. Opioid Opana ER, approved in 2006, is too risky, the FDA says. Currently, there are no generic versions on the market.
Endo International PLC said recently that it will voluntarily stop selling the pills, approved for use in patients with severe, constant pain, after consulting with the U.S. Food and Drug Administration. It’s the first opioid drug that the FDA has sought to remove from the market due to 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 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.
Besides contributing to overdoses, abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles, according to the FDA. The agency asked the company to stop selling Opana ER after its advisers reviewing its safety at a March hearing, voted 18-8 against keeping it on the market.
Endo sold $35.7 million worth of Opana ER in the first three months of 2017 and $158.9 million last year. 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.
According to the US Centers for Disease Control and Prevention, the United States is in the midst of an opioid overdose epidemic. Opioid overdose killed more than 33,000 people in 2015, more than any year on records. Nearly half of all overdose deaths involve some kind of prescription drug.
As a partner with D'Arcy Johnson Day, Andrew D'Arcy has been involved in some of the nation’s most high-profile cases and investigations, including a number of mass product/drug defect and environmental toxic tort cases. Additionally, he has been named a “Super Lawyer” by New Jersey Monthly Magazine every year since 2013.