Donnelly said, "This is welcome news, and I am pleased by the FDA's action". The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse". Increased needle-sharing of the drug has since been linked to serious blood disorder cases in Tennessee in 2012 and a 2015 outbreak of HIV and hepatitis C in IN, officials said.
Thursday's announcement followed a March vote from an independent group of experts, brought together by the FDA, who voted 18-8 that the benefits of reformulation no longer outweighed the risks.
The drug was reformulated in 2012 in an attempt to make the medication more hard for people to abuse; specifically, the drug makers sought to make it hard for users to snort or inject the drug.
The FDA said it made its latest decision based on a review of all post-market data, which suggested that when the company reformulated the medication, people were injecting it more than they were snorting it. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. When the company submitted its reformulated version to the FDA in 2012, the agency decided the data weren't strong enough to show that it could "meaningfully reduce abuse", and the agency denied a request to include a label that would describe its reformulation as having abuse-deterrent properties.
Endo has had other issues with the FDA and the drug.
The FDA has been reviewing the drug's risks for several months.
The FDA says it has seen a "significant shift" from people crushing and snorting Opana ER to get high to injecting it.
Endo first got USA approval for its extended-release opioid, Opana ER, in 2006.
"When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", Woodcock added in a statement.
The agency has been criticized in the past for examining the safety and effectiveness of individual opioid painkillers without considering the wider impact each could have on the nation's epidemic. Officials with the FDA have requested that the company voluntarily remove reformulated Opana ER from the market, but if the company refuses, "the agency intends to take steps to formally require its removal by withdrawing approval". "This action will protect the public from the further potential for misuse and abuse of this product". In the meantime, the FDA is making healthcare professionals aware of the risks associated with the powerful painkiller.
Randall Stanicky, an analyst at RBC Capital Markets, said Opana ER is a declining asset whose sales are expected to fall to US$97 million in 2019, down from an estimated US$134 million in 2017.