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.
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. It reformulated that drug in 2012 and claimed the changes made it harder to manipulate physically or chemically to abuse it. Endo tried to persuade FDA officials that the new formulation was abuse-resistant, which likely would have given the product a marketing advantage in the crowded, lucrative category of opioid painkillers.
Endo's stock was down more than 14% after-hours on Thursday. "When we determined that the product had risky 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.
Endo first got US approval for its extended-release opioid, Opana ER, in 2006.
The company must now choose between voluntarily taking Opana off the market or face an impending formal FDA drug approval withdrawal. 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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He has recommended new FDA policy that requires mandatory education on opioid abuse for healthcare professionals, limiting the number of doses a patient can be prescribed, and giving more scrutiny to new opioid drugs during their review. It will continue to review the risks and benefits of other similar drugs, the agency said. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market".
The United States in in the midst of an opioid overdose epidemic, according to the US Centers for Disease Control and Prevention.
Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".
TRENTON, N.J. (AP) - U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it. 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.
Opana ER brought in $158 million in sales past year for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site.