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Benefits of Opioid Painkiller Opana ER No Longer Outweigh Its Risks, FDA Panel Says

Agency considers regulatory action

A panel of FDA advisers has concluded that the benefits of an opioid painkiller linked to a 2015 outbreak of human immunodeficiency virus (HIV) infection in Indiana no longer outweigh its risks, according to an article in the Wall Street Journal. The FDA asked the experts to review the drug, Opana ER (extended-release oxymorphone, Endo Pharmaceuticals), after concerns mounted about its safety. The FDA cited particular concerns about the HIV outbreak in rural Austin, Indiana, which was caused by opioid addicts sharing needles while injecting Opana ER.

The panel voted 18 to 8 that the painkiller’s benefits no longer outweigh its risks, with many saying the drug’s formulation appeared to encourage risky forms of injection-drug abuse that could help spread viruses, including HIV, according to the Journal.

Several experts recommended removing Opana ER from the market, whereas others said the drug’s use should be restricted, with only pain specialists allowed to prescribe it.

The FDA must now decide whether to take regulatory action against the drug. The agency isn’t required to follow the advice of its advisory committees, but typically does.

The FDA panel reviewed a reformulated version of Opana ER tablets that was launched in 2012. At the time, Endo Pharmaceuticals said the new version would be harder to abuse because it was designed to be more difficult to crush. Moreover, the company said, the new version forms a “viscous gel” when mixed with liquids to make the drug more difficult to inject, according to documents the FDA prepared for the hearing.

But an FDA expert reported at the hearing that the reformulation had the unintended consequence of shifting addicts from snorting the drug to injecting it.

Opana ER also has a relatively short duration of action in the body, which can encourage addicts to inject the drug multiple times a day, and in turn may also increase the odds of virus transmission, some of the experts said.

In a press statement, Endo Pharmaceuticals said that it believes Opana ER “remains an important clinical choice for appropriate patients” and that the company “will evaluate the range of available options for maintaining access for legitimate use.”

Opana ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Sources: Wall Street Journal; March 14, 2017; and Endo Pharmaceuticals; March 14, 2017.

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