FDA Calls On Drugmaker To Pull A Powerful Opioid 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. But the agency says Endo's attempts to reformulate the pills to make them harder to crush, dissolve and inject have not been successful. "When we determined that the product had unsafe 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. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse".

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".

Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

The agency said that the decision came after it found that the drug's benefits no longer outweighed its risk for abuse. The pill became notorious after it was blamed for prompting an HIV outbreak in rural in in 2015, and it was also linked to reports of a rare but serious blood disease characterized by clots that can lead to organ damage. As a result, some who abuse Opana ER are injecting the drug more frequently.

About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin. Post-marketing data showed a significant shift in the route of abuse from nasal to injection, the FDA said. If the company does not choose to do so voluntary, the FDA will force the issue by withdrawing its approval for the drug.

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Donnelly said, "This is welcome news, and I am pleased by the FDA's action".

"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, in fact, determined the reformulation was not expected to "meaningfully reduce abuse" and declined to let the company describe the drug as abuse deterrent in the product labeling.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".

For the first time ever, the Food and Drug Administration has asked a drug company to pull a painkiller off the market because it has such a high potential for abuse.

Endo had about $4 billion in revenue past year, only $159 million of that from Opana.

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