The U.S. Food and Drug Administration (FDA) has called for Endo Pharmaceuticals to remove its reformulation of oxymorphone hydrochloride extended-release, Opana ER, because of the potential for the drug to be misused.
This is the first case in which the agency has requested a manufacturer to pull an opioid medication because of public risk. FDA Commissioner Scott Gottlieb, MD, called it a “necessary step” to reduce the “scope of opioid misuse and abuse.”
The FDA reached this decision following a review of post-market data of the drug’s reformulation; the panel of experts voted 18-8 in support of removing the product from the market, claiming that the benefits of Opana ER no longer outweigh the risks.
Opana ER was approved by the FDA in 2006 for the management of moderate to severe pain when a continuous opioid analgesic is needed for an extended period of time. Addressing concerns about the drug’s potential for abuse, the manufacturer developed an abuse-deterrent reformulation of the drug in 2012. Though the product met standards for approval, the FDA’s current review of data found that the reformulation did not reduce abuse. In addition, the route of Opana ER abuse has shifted from nasal to injection. Injection abuse has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy.
The FDA’s request is not mandatory, but should Endo Pharmaceuticals decline to remove the product, the FDA “intends to take steps to formally require its removal by withdrawing approval,” according to a statement. “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.”
Source: FDA news release, June 8, 2017.