Earlier this year, the Food and Drug Administration took the rare step of pressuring a drug company to stop selling an opioid painkiller that was widely abused. But as CNN recently reported, before it halted sales of Opana ER, Endo Pharmaceuticals cut a deal with a competitor to split profits on a generic version of the drug still on the market.
The head of the FDA, Scott Gottlieb, reacted on Friday announcing that his agency is reviewing data and will decide whether to take action on other versions of the drug.
“I recently have seen media reports stating that Endo is participating in a re-launch of the old version of Opana ER,” he told reporters in a speech at the National Press Club in Washington.
Endo voluntarily withdrew the original version of Opana ER in 2012, arguing that the drug was susceptible to abuse. But before it stopped selling the original version, Endo replaced it with a new version of Opana ER with a hard coating that made it harder to crush and snort.
Drug abusers, however, quickly learned how to melt the new crush-resistant pill and inject it. Opana ER is more potent than either oxycodone or morphine. Abusers told researchers they preferred the drug because the high was so intense.
Injecting Opana ER was linked to outbreaks of HIV, hepatitis C and a rare blood disorder.
The FDA determined this summer that the risks of new version of Opana ER outweighed the benefits. But the agency did not reach any conclusions on the original version of the drug, including a generic version still on the market.
Gottlieb, however, said the FDA has been studying oxymorphone, the active ingredient in Opana ER, to determine whether it is more likely to be abused than other opioids. Data presented at a FDA hearing in March showed that generic oxymorphone has the highest abuse rate of any opioid.
“If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, FDA would consider taking regulatory actions that could limit patient exposure to oxymorphone,” he said.
In declaring opioid addiction a national public health emergency, President Trump referred to Opana ER as a “truly evil” opioid that was taken off the market.
Endo said Friday that it has no plans to relaunch the original version of Opana ER. However, Impax Laboratories has been selling a generic version of the original formulation of Opana ER since 2013. Endo still holds the patent on the drug. In August, it announced a deal with Impax Laboratories to split profits on the generic version of original Opana ER – the same drug Endo said it pulled off the market for safety reasons.
“While Endo has no plans to reintroduce the original formulation of Opana® ER, Endo’s 2017 settlement agreement with Impax Labs resolved the parties’ existing litigation relating to their 2010 patent settlement and allows Endo to be fairly compensated for Impax’s license to Endo’s valuable intellectual property in offering that product for use as intended and as approved by FDA,” the company said.