In the midst of an ever-worsening epidemic of opioid abuse and overdose-related deaths in the U.S., the Food and Drug Administration (FDA) has hinted that it finally may be willing to flex its regulatory muscle to more effectively respond to this public health crisis. On June 8, the agency announced that it had requested that Endo Pharmaceuticals remove from the market its reformulated extended-release oxymorphone opioid product, OPANA ER. The FDA took this action based on concerns that...
In the midst of an ever-worsening epidemic of opioid abuse and overdose-related deaths in the U.S., the Food and Drug Administration (FDA) has hinted that it finally may be willing to flex its regulatory muscle to more effectively respond to this public health crisis. On June 8, the agency announced that it had requested that Endo Pharmaceuticals remove from the market its reformulated extended-release oxymorphone opioid product, OPANA ER. The FDA took this action based on concerns that the drug’s benefits no longer outweigh its risks.
OPANA ER was first approved by the FDA in 2006 for treatment of moderate-to-severe pain. In 2011, Endo sought approval of a new form of the drug that was purported to have “abuse-deterrent” features that would make it more difficult for people to abuse the drug by snorting or injecting it. Although the FDA approved the reformulated drug, the agency rejected the company’s request to include in the product labeling a claim that the drug was abuse-deterrent, citing a lack of evidence that it could meaningfully reduce abuse.
Disturbingly, before its approval in 2011, the FDA had data suggesting that the new version of OPANA ER could be abused more easily by the injection route than the original version of the drug. Thus, not only was the new formulation not abuse-deterrent, there was worrisome evidence that it could actually facilitate injection abuse.
Subsequent studies have indeed showed that after the FDA approved the new form of OPANA ER, there was a significant shift in the route by which people abused the drug from predominantly nasal to predominantly injection. In 2015, a severe outbreak of HIV and hepatitis C infections in Indiana was linked to injection abuse of OPANA ER using shared needles. Injection abuse of the drug also was associated with cases of a serious blood disorder that can cause bleeding, kidney failure and brain damage.
In March, an FDA advisory committee was convened to consider the safety and abuse potential of reformulated OPANA ER. Dr. Sidney Wolfe, founder of and senior adviser to Public Citizen’s Health Research Group, testified at the meeting and argued that the drug should be withdrawn from the market. Eighteen of 26 experts on the committee wisely concluded that the benefits of the drug did not outweigh its risks.
Wolfe applauded the FDA’s call for Endo to remove OPANA ER from the market but sharply criticized the agency for approving the reformulated drug in the first place and blasted Endo for suggesting that it may not acquiesce to the FDA’s request. If Endo fails to act soon, the FDA must move swiftly to protect public health by withdrawing its approval of the drug.
 Food and Drug Administration. FDA news release: FDA requests removal of Opana ER for risks related to abuse. June 8, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm. Accessed June 14, 2017.
 Food and Drug Administration. FDA briefing document: Joint meeting of the Drug Safety and Risk Management (DSaRM) Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). March 13-14, 2017. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM545760.pdf. Accessed June 15, 2017.
 CBS News. FDA to drugmaker: Yank opioid Opana ER from market. June 9, 2017. http://www.cbsnews.com/news/fda-opioid-epidemic-endo-pharmaceuticals-opana-er/. Accessed June 14, 2017.
 Wolfe S. Testimony before the FDA Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees: Reformulated Opana ER: extended release oxymorphone and general discussion about abuse deterrence. March 14, 2015. https://www.citizen.org/sites/default/files/2365.pdf. Accessed June 15, 2017.
 Food and Drug Administration. Summary minutes of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee joint meeting. March 13-14, 2017. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM551226.pdf. Accessed June 15, 2017.
 Public Citizen. FDA never should have approved Opana ER. June 9, 2017. https://www.citizen.org/media/press-releases/fda-never-should-have-approved-opana-er. Accessed June 15, 2017.