Opioid Painkiller Opana Deemed Too Dangerous by FDA Panel

Opana ER, a powerful prescription opioid painkiller, presents too great a risk of abuse and should be removed from the market, according to a recently assembled FDA Advisory Panel. The panel consisting of doctors, researchers and academics, found the risks of abuse outweigh its potential benefits in alleviating pain.

Opana ER, manufactured by Endo Pharmaceuticals, was first released to consumers in 2006 in pill form. Endo says Opana ER was intended to treat “pain severe enough to require daily, around the clock, long-term opioid treatment.” When used as intended and taken orally, it is twice as potent as Oxycontin and provides 12 hours of pain relief. Problems arise when opioid patients begin crushing and snorting the painkiller, thereby receiving 12 hours of pain relief in one huge dose. Not surprisingly, abuse, addiction, and overdose deaths soon follow.

In 2012, Endo reformulated Opana ER with a special coating in an attempt to stop its abuse through snorting. Undeterred addicts soon figured out a way to dissolve and inject the potent painkiller, bringing with it an HIV outbreak in communities like Scott County, Indiana, which reported 215 HIV cases in 2015, the majority of which occurred from injecting Opana ER with shared needles. Indiana state health commissioner Dr. Jerome Adams spoke with the FDA advisory panel and bluntly told them, “You need to ask yourself, ‘Are you helping more people than you’re hurting?”

NPR reported Endo’s reformulation was not purely humanitarian, however, a profit motive also played a role in the decision. As time was drawing near for Endo to lose its patent on this drug that brought $135 million in net profits each year, Endo’s decision to reformulate Opana ER was also an attempt to eliminate competition from generic drug manufacturers.

The FDA approved the reformulated drug, and Endo filed a petition asking the FDA to prevent generic formulations of the drug arguing there would be an uptick in abuse from non-crush proof generic versions of the drug on the market.  In 2013, the FDA determined the reformulated version of Opana ER did not significantly deter abuse, and warned of “the troubling possibility that a higher percentage of reformulated Opana ER abuse is via injection that was the case with the original formulation.” Survey results from people being treated for drug abuse who abused Opana ER supported this conclusion showing that the number of people injecting Opana after its reformulation doubled from 17% to 38%.

Additionally, injecting reformulated Opana can cause rare blood disorders and Hepatitis C, in addition to HIV.

After reviewing all the findings, the advisory panel voted 18-8, with one abstention, that the benefits of reformulated Opana ER do not outweigh the risks of abuse. Several members of the panel advocated for Opana’s removal from the market altogether. Those members voting in the minority contend removing Opana from the market would do nothing to stop the opioid abuse epidemic, as addicts would simply find an alternative opioid to feed their addiction, such as heroin or fentanyl.

Despite the panel’s findings, Endo stands behind the efficacy of its reformulated Opana ER when used appropriately.

The panel’s findings are not binding on the FDA, and there is no deadline for action or a finding by the FDA. The FDA has several options available to it: it can require labeling changes by Endo; remove Opana ER from the market; or, do nothing at all.

Tags: (pharmaceutical lawyer, pharmaceutical recall)