Home E-Weekly June 13, 2017

FDA Asks Endo to Withdraw Opana ER

Published: June 12, 2017

CRISIS MANAGEMENT "We must take all necessary steps to reduce the scope of opioid misuse and abuse," said FDA Commissioner Scott Gottlieb, MD, regarding the agency's request to the maker of Opana ER.

For the first time ever, the Food and Drug Administration has asked a drug maker to pull a currently marketed opioid pain medication off the market over concerns that the drug is too easily abused.

It's not clear whether Endo Pharmaceuticals will comply with the FDA's request to voluntarily remove Opana ER, an extended release form of oxymorphone hydrochloride that is easily crushed up and injected by people seeking to abuse it. The FDA says it will withdraw Opana ER's approval if Endo doesn't voluntarily pull the drug from the market.

Ironically, Endo reformulated Opana in 2012 to make it a crush-resistant product. A hard coating on the new pills made them more difficult to crush into a fine powder so abusers could snort the medicine in the pill to get the full effect of the extended-release drug immediately. But the FDA says more people found a way to remove the reformulated drug's coating and inject it. This "significant shift in the route of abuse" led to needle sharing and sparked an outbreak of HIV and hepatitis C in Indiana, as well as cases of a rare blood disorder in Tennessee.

An independent FDA advisory committee voted 18-8 (1 abstention) that the benefits of reformulated Opana ER no longer outweigh its risks. In a statement, Endo noted that, despite the outcome of the vote, several committee members felt the drug should remain on the market with additional regulatory restrictions to mitigate the risk.

Endo says it is reviewing the request and "evaluating the full range of potential options," adding that the request "does not indicate uncertainty with the product's safety or efficacy when taken as prescribed." The company remains confident in the clinical research demonstrating Opana ER's "favorable risk-benefit profile when used as intended in appropriate patients."

Should Endo choose not to remove the product, the FDA says it intends to withdraw its approval, thereby formally requiring its removal. Furthermore, the FDA says it will continue to examine the risk-benefit profiles of all approved opioid analgesic products and, when appropriate, take action in response to the ever-growing opioid crisis.

"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 FDA Commissioner Scott Gottlieb, MD. "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."

Bill Donahue

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