An FDA advisory panel ruled yesterday that the benefits of Endo Pharmaceutical‘s opioid painkiller, Opana ER, no longer outweigh its risks. The painkiller has been linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana.
The panel voted 18 to 8 that the drug’s benefits do not outweigh the risks, with some advisers concluded that the drug’s formulation seemed to encourage risky forms of injection drug abuse.
Endo brought the reformulated version of Opana to the market in 2012, saying that it was an “abuse-deterrent” version of the opioid since it was designed to be more difficult to crush. The painkiller also forms a “viscous liquid” when mixed with solvents, making it tougher to inject.
However, experts found that the reformulation had several unintended consequences. Instead of snorting the drug, addicts began injecting it by mixing the painkiller with large volumes of solvent.
“We believe the data are compelling that among those abusing Opana ER, the reformulation caused a shift from the nasal to the injection route,” FDA physician and epidemiologist Jana McAninch reportedly said at the hearing.
The increased volumes of solution may have encouraged addicts to share the same syringe, which would increase the likelihood of transmitting viruses like HIV, the panelists added.
While some of the panelists recommended taking Opana off the market completely, others said the drug’s use should be restricted.
The FDA will now have to decide whether to follow the advisory committee’s recommendation and level regulatory action against the drug.
“Endo remains confident that the body of evidence established through clinical research demonstrates that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients,” Endo’s senior VP of R&D Dr. Matthew Davis said in prepared remarks. “Our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options. We plan to work collaboratively with the FDA as the Agency completes its evaluation of Opana ER, while advocating to preserve the important benefits of the medicine for patients.”
The panel’s conclusion comes at a time where opioid abuse is rampant in the U.S. – 91 Americans die every day from an opioid overdose, according to the Centers for Disease Control & Prevention.