FDA to drug maker: Pull opioid pain drug

FDA has requested that Endo Pharmaceuticals remove its opioid pain medication, Opana ER (oxymorphone hydrochloride) from the market due to the agency’s concerns that the benefits of the medication do not outweigh its risks related to abuse.

This is the first time that the FDA has asked a manufacturer to remove its opioid pain medication from the market due to the public health consequence of abuse and the agency says it will continue to examine the risk-benefit profile off all approved opioid analgesics and take actions appropriately as part of the response to the opioid epidemic.

Higashi

“FDA putting its foot down to have this drug removed as a legal prescription is what is needed with the current opioid epidemic,” said Stephanie Higashi, DC, chief executive of the integrated healthcare practice HEALTH ATLAST. “Allowing for highly addictive medications to be provided to patients who may not be told the extreme risks may result in a lifetime of pain, addiction, loss and even death.”

According to Higashi, “Given that Opana has a high risk of abuse and is dangerously addictive, it is even more critical to have it removed from the market. The drug also has a very long half-life, meaning the amount of time it stays in the body and it takes the body to metabolize the drug out of the body.”

Oxycodone, for example has a half-life of approximately 3.5 hours whereas Opana has half-life 7 to 9 hours, according to Higashi. “Thus, the drug is kept in the body longer and even more dangerous if a person is to have a reverse reaction it is in their body longer than something that would wear off after a few hours.”

According to the CDC, deaths from prescription opioids, like oxycodone, hydrocodone, and methadone, have more than quadrupled since 1999 and it is estimated that 91 Americans die every day from an opioid overdose, including prescription opioids and heroin.

Opana ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Opana ER was first approved in 2006 but in 2012, Endo Pharmaceuticals replaced the original formulation with a new formulation that was intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

The new formulation did meet the regulatory standards for approval. However, FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and therefore declined the manufacturer’s request to include labeling describing potentially abuse-deterrent properties for the new formulation of Opana ER.

FDA’s decision to ask for removal of the opioid pain drug is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Abuse by injection of the reformulated drug has been associated with an outbreak of HIV and hepatitis C, as well cases of thrombotic microangiopathy, a potentially life-threatening condition caused by small-vessel platelet microthrombi.

“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,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”

Meanwhile, FDA wants healthcare professionals and others to be aware of the potentially serious risks associated with the abuse of Opana ER.