Endo Pharmaceuticals today bowed to the FDA’s June 2017 request that it pull Opana ER from the marketplace, on the grounds that the opioid drug’s potential for abuse and misuse far outweighed its benefit. 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.
“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb, M.D. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
The FDA say the company’s efforts to reformulate the drug accomplished little and basically did little more than change the way that consumers abused it, possible leading to serious outbreaks of HIV and hepatitis C.
Snorting and injecting Opana ER
“After careful consideration and consultation with the FDA following the FDA’s June 2017 withdrawal request, the Company has decided to voluntarily remove Opana ER from the market,” the company said in a July 6 press release. “Endo International plc continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse.”
Company officials said that neither the FDA’s request or Endo’s decision to remove Opana ER from the market indicates that the drug is unsafe.
The FDA said its decision was based on a review of data that demonstrated a “significant shift in the route of abuse of Opana ER” 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, as well as cases of a serious blood disorder (thrombotic microangiopathy). 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,” the FDA said in its June advisory.
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 while the product met the regulatory standards for approval, 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.