The Food and Drug Administration (FDA) has requested the removal of reformulated Opana ER (oxymorphone HCl; Endo) from the market. This marks the first time the Agency has proposed to remove a currently available opioid pain medication from the market due to the possible consequences of misuse and abuse.
In March 2017, the FDA Advisory Committee had voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks. After a review of all postmarketing data, the Agency observed a significant shift in the route of abuse from nasal to injection after Opana ER was reformulated. The abuse of reformulated Opana ER via injection has been linked to a serious outbreak of HIV and hepatitis C infections in addition to thrombotic microangiopathy.
Opana ER, an opioid agonist, was approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is required for an extended period of time. The original Opana ER was reformulated in 2012 to be more resistant to physical and chemical manipulation for abuse by snorting or injection. The reformulated Opana ER met the regulatory standards for approval but the FDA determined that the data did not demonstrate it could meaningfully reduce abuse.
Endo’s request to include potentially abuse-deterrent properties in the Opana ER labeling was subsequently denied. After evaluating more data on the risks of the reformulated version, the FDA is moving to remove reformulated Opana ER from the market.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, stated, “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.” If the manufacturer chooses not to remove Opana ER, the FDA plans to take steps to formally require its removal by withdrawing approval.
For more information visit FDA.gov.