OPANA ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
This marks the first time the FDA has ordered the removal of a previously approved opioid painkiller from the market due to abuse and addiction. The reformulation coated the pills in a way that made them hard to snort, but addicts shifted towards crushing and injecting the painkiller.
The FDA was also able to link the shift from inhaling Opana to injecting it with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy, a risky blood disorder.
Endo complied in pulling the extended-release drug from the market as many of those prescribed with the medication have been abusing it.
"With Opana ER now officially being pulled, focus shifts to protecting the potential lost EBITDA margin associated with the product, which we estimate to be in the range of 60.0% to 65.0%", wrote Raymond James analyst Elliot Wilbur in a note on Thursday, July 6.
In its announcement, Endo said that it will work with the FDA to coordinate and remove the drug in a way that will "minimize treatment disruption for patients" and allow "patients sufficient time to seek guidance from their healthcare professionals".
Endo primarily makes generic medicines, as well as a number of brand-name specialty drugs. The move will cost Endo $20 million, the company said.
Friday, the FDA asked that Opana ER be taken off the market after what they call careful consideration.
The agency said it would also review other opioid painkillers and could take further action.