The Food and Drug Administration on Thursday asked a drug company to remove its opioid pain medication from the market, the first time the agency has made such a request because of the public health consequences of abuse.
The agency concluded after an extensive review of Endo Pharmaceuticals’ Opana ER that the “benefits of the drug may no longer outweigh its risks.” The company reformulated the drug in 2012 to make it more difficult to snort, but the FDA said that move actually led to more injections – and a major HIV outbreak.
FDA Commissioner Scott Gottlieb, who has pledged to take “more forceful” steps to curb the nation’s opioid epidemic, said the agency’s action reflects its increased focus on the risks posed by the illicit use of opioids. The FDA “is looking broadly at the whole policy framework” used for the painkillers, he said in an interview Thursday.
The medication was approved in 2006 for moderate-to-severe pain when a round-the-clock painkiller is needed. During the drug’s reformulation, Endo introduced a coating designed to deter people from crushing and snorting the medication. But the FDA declined to give it an “abuse deterrent” label, saying the data didn’t support such a designation.
The FDA said Thursday that subsequent data showed a “significant shift” in the route of abuse “from nasal to injection” after the reformulation. 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 Indiana, officials said.
In March, an FDA advisory committee voted 18-8 that the benefits of the reformulated Opana ER no longer outweighed the risks it posed.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement Thursday. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.”
If the company declines to remove the product, the FDA will take steps to formally require its removal by withdrawing agency approval.
In a statement, the company said it was reviewing the FDA’s request but that it “remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”
Michael Botticelli, director of the Office of National Drug Control Policy for nearly three years under President Barack Obama, called the FDA action “a real encouraging step. It sounds as if the FDA is using expanded criteria in the way they look at opioids.”
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.
“This falls in line, I think, with their recently released guidance on how they were going to think of drugs and drug approval,” Botticelli said.
From 2000 to 2015, nearly 180,000 Americans died from overdoses of prescription opioids, and tens of thousands more have succumbed to heroin and fentanyl overdoses as the crisis has evolved.
Opana ER brought in $158 million in sales last year for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site. The company, which is based in Dublin and has its U.S. headquarters in Malvern, Pennsylvania, recently announced two rounds of job cuts.