In early June, the FDA requested that Endo Pharmaceuticals voluntarily remove its opioid pain medication, reformulated Opana® ER (oxymorphone hydrochloride), from the market, based on their concern that the benefits of the drug may no longer outweigh its risks.
Opana ER is an opioid originally approved in 2006 for the treatment of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is necessary. In 2012, Opana ER was reformulated to deter snorting and injecting, however, the FDA did not find that the reformulation could be expected to meaningfully reduce abuse.
A March 2017 FDA advisory committee meeting of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks. A review of all available postmarketing data demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following reformulation. Such injection abuse has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).
This was the first time the FDA has taken steps to remove a currently marketed opioid from sale due to the public health consequences of abuse. Should the company choose not to remove the product, the FDA intends to take steps to formally require its removal by withdrawing approval.
One week later, FDA Commissioner Scott Gottlieb, M.D., announced a public meeting to discuss if abuse-deterrent opioids are having their intended impact on limiting abuse to help curb the opioid epidemic.
“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof,” said Commissioner Gottlieb, acknowledging gaps in the FDA’s understanding of whether abuse-deterrent opioids result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse.
The meeting will be held July 10-11 in Silver Spring, Maryland. External thought leaders will discuss how the FDA can better leverage existing data sources and methods to evaluate the impact of abuse-deterrent opioids in the real world, as well as what new data sources and study designs could be developed or enhanced to ensure these efforts result in the best possible answers to inform regulatory decision-making.
To attend the public workshop, stakeholders must register by June 26 at http://www.cvent.com/d/r5qc6n/4W.
These recent actions are part of an extended action plan the FDA is undertaking to address the opioid epidemic, which includes the formation of a steering committee to examine additional regulatory and policy actions that can further combat opioid misuse and abuse.
Healthesystems recently published an article examining the limitations of abuse-deterrent opioids in curbing misuse within injured worker populations.