FDA Asks Drug Company to Pull Its Opioid Opana Because of Abuse

Posted June 09, 2017

The FDA indicated that if Endo declines to remove Opana ER voluntarily, the agency would withdraw approval for the opioid.

The FDA said that reformulation made things worse. "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".

Endo is reviewing the FDA's request and evaluating all its options "as we determine the appropriate path forward", it said in a statement. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse".

Although a reformulated version of Opana ER had been approved in 2013 to discourage its abuse, people abusing the drug simply changed from inhaling it to injecting it, which led to serious outbreaks of HIV and Hepatitis C, the statement said.

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. Despite the advisory committee vote in March, Endo said that more than half the panel members "expressed their preference that Opana ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse".

It was 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, the FDA said.

The drug was reformulated in 2012 in an attempt to make the medication more hard for people to abuse; specifically, the drug makers sought to make it hard for users to snort or inject the drug.

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Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention.

As STAT has noted previously, Opana ER is meant to be swallowed and the contents released over 12 hours, which is known as extended release.

FDA officials said their decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of the reformulated product from nasal to injection following the product's reformulation. Other states and cities have filed similar lawsuits.

The company, attempting to fight drug abuse, claimed to have reformulated the drug so that it could not be crushed or molded for snorting or injection.

"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. "This action will protect the public from further potential for misuse and abuse of this product".

Last year, Opana ER generated almost $159 million in revenue, although sales have slowed more recently.