The FDA just requested that Endo International take its extended-release opioid painkiller Opana ER (otherwise known as oxymorphone hydrochloride) off the market.
"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.
The FDA said that reformulation made things worse. Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits". "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
This is one of the first policy decisions by the agency since Scott Gottlieb was appointed FDA commissioner by President Trump, who had talked about the opioid crisis during his campaign. The move follows an FDA advisory committee vote of 18-8 in March concluding the drug's risks were greater than the benefits.
Endo has had other issues with the FDA and the drug.
"While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S. As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products".
"When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", says Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin.
Endo, which sold $158 million worth of Opana ER in 2015, had reformulated the pills in 2012 and sought to get them labeled as abuse deterrent.
"When we determined that the product had risky and unintended consequences, we made a decision to request its withdrawal from the market", Woodcock said. Although the reformulated drug was approved, the FDA later determined that this change did not "meaningfully reduce abuse".
Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".
Opana ER brought in $158 million in sales a year ago for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site.