FDA seeks to ban opioid Opana ER

Powerful narcotic has history of abuse

The U.S. Food and Drug Administration this week sought to remove from the market a powerful narcotic with a long history of abuse.

It was the second time the agency had to reverse course and seek removal of the drug because of its widespread abuse.

Most recently the drug has been linked to outbreaks of HIV and hepatitis C in rural Indiana and Kentucky, Tennessee, West Virginia and Virginia among needle-sharing addicts who crushed the drug and injected it.

“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,” FDA Commissioner Scott Gottlieb said in a statement.

After careful consideration, the agency said, it is seeking removal of the drug Opana ER because it believes its benefits no longer outweigh its risks.

The drug was the subject of

a 2015 Journal Sentinel/ MedPage Today investigation that raised questions about why the FDA had allowed the drug back on the market in 2006 after a similar product had been removed in 1979 following abuse by addicts in the 1960s and ‘70s.

Independent experts were critical of the FDA’s 2006 decision to allow it back on the market. They noted the re-approval came amid a burgeoning opioid epidemic that already had taken tens of thousands of lives.

They also noted that there already were more than a dozen opioid products on the market.

“They never should have allowed Opana back on the market,” said Andrew

Kolodny, an addiction specialist and co-director of the Opioid Policy Research Collaborative at Brandeis University. “We never needed it. We had plenty of opioid options.”

The Journal Sentinel/ MedPage Today story also noted that the decision to allow Opana back on the market in 2006 came after a series of private meetings at expensive hotels between opioid companies and regulators in which the drug companies paid fees of up to $35,000 to allow their executives to talk to FDA officials about how to get their drugs on the market.

One of those companies was Endo Pharmaceuticals, the maker of Opana ER.

Endo Pharmaceuticals was a frequent participant at meetings of the drug company fund organization known as IMMPACT. It was the subject of a 2013 Journal Sentinel/MedPage Today investigation.

Opana is known generically as oxymorphone.

In the 1960s and ‘70s it was known as Numorphan. As Numorphan, the drug’s popularity among addicts was due to its quick and sustained effect, according to the 1974 report “Drugs and Addict Lifestyle” by the National Institute on Drug Abuse.

The report said the drug — which carried the street name “blues” — was used primarily by white males. The report focused on 309 Philadelphia-area Numorphan addicts who were interviewed in 1970, with many saying they preferred the drug over heroin. The drug was taken off the market in 1979.

After initially approving Opana as both an immediate-release and extended-release product in 2006, the FDA in December 2011 approved a formulation designed to prevent abuse by making the drug tough to crush or dissolve.

But users were able to foil the anti-injection mechanism and have continued to shoot up Opana. The drug is 10 times more potent than morphine when it is injected.

That injection abuse and sharing of needles led to the outbreak of HIV and hepatitis C.

Instead of removing the drug from the market, the FDA has asked Endo Pharmaceuticals to voluntarily take it off.

If the company does not, the FDA said, it will take steps to formally withdraw the product. In the meantime, the agency is warning health care professionals about its risks.

The FDA said it will continue to examine the risk-benefit profile of all approved opioid products and take further actions “as appropriate as a part of our response to this public health crisis.”

In a statement, Endo Pharmaceuticals said it is reviewing the FDA’s request and evaluating “a full range of options.”

“Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed,” said spokesperson Heather Zoumas-Lubeski.

“Endo 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.”

“They never should have allowed Opana back on the market. We never needed it. We had plenty of opioid options.”

ANDREW KOLODNY, ADDICTION SPECIALIST AND CO-DIRECTOR OF THE OPIOID POLICY RESEARCH COLLABORATIVE AT BRANDEIS UNIVERSITY