This marks the first time the FDA has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of opioid abuse. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research said in the FDA's prepared statement.
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The FDA move comes after advisers, reviewing the safety of Opana ER at a March hearing, voted 18-8 against keeping it on the market. "This is the first time the agency has taken steps to remove a now marketed opioid pain medication from sale due to the public health consequences of abuse".
If Endo refuses to withdraw the product, the FDA could offer the company an opportunity for a hearing to make the case for why the product should not be removed.
Opana ER (oxymorphone hydrochloride) was first approved by the FDA in 2006 for use by people with moderate or severe chronic pain.
The FDA said that reformulation made things worse.
An FDA review of available data on the drug found that the way people abuse the medication had shifted significantly after its reformulation, changing from snorting to injection. The FDA intends to continue issuing warnings and informing the public about the risks of Opana use in the meantime.
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About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin.
"We are facing an opioid epidemic - a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse", says Dr. Scott Gottlieb, the FDA's commissioner, in announcing the move.
Endo had touted the new formulation as abuse-resistant, though the FDA did not allow the company to market it as such when granting approval for sales several years ago.
As public health authorities and the FDA became increasingly concerned about the nation's epidemic of opioid abuse and overdoses, the company reformulated the drug in 2012, by adding a coating that was meant to make it harder to snort or inject the medicine. "This action will protect the public from further potential for misuse and abuse of this product".
The move coincides with a lawsuit filed on May 31 against the pharmaceutical industry by OH, charging that a number of companies, including Endo, Purdue Pharma, Teva Pharmaceutical Industries Ltd, Johnson & Johnson and Allergan Plc conducted misleading marketing campaigns that downplayed the drugs' addictiveness.
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.