Officials with the FDA have requested that Endo Pharmaceuticals remove its opioid pain medication, oxymorphone hydrochloride (reformulated Opana ER), from the market, noting that "after careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks."
This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse, according to a prepared statement from the FDA.
FDA officials said their decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of the reformulated product from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C in Indiana.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the FDA's prepared statement. “This action will protect the public from further potential for misuse and abuse of this product.”
This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting, but the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Officials with the FDA have requested that the company voluntarily remove reformulated Opana ER from the market, but if the company refuses, "the agency intends to take steps to formally require its removal by withdrawing approval."
"The FDA will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis," according to the FDA statement.
FDA requests removal of Opana ER for risks related to abuse [news release]. Gaithersburg, MD. FDA website. Accessed at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm. June 8, 2017.