The Food and Drug Administration (FDA) is awaiting results from a commissioned study to evaluate whether the powerful opioid oxymorphone, which is the active drug ingredient in Endo Pharmaceuticals’ painkiller Opana ER, is more likely to be abused than other opioids.
“If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, the FDA will consider taking regulatory action that could limit patient exposure to oxymorphone,” said FDA Commissioner Scott Gottlieb.
Gottlieb made the statement during a speech to the National Press Club in Washington, D.C., during which he also said he is taking action to reduce the level of nicotine in cigarettes sold in the U.S. Both actions are part of the agency’s efforts to fight substance abuse.
In July, Endo pulled Opana ER from the market after months of pressure by the FDA. The agency said that a review of marketing data showed a significant shift in the abuse of Opana ER from being snorted to being injected after the company reformulated the painkiller to resist crushing. The data showed that injection with the reformulated Opana ER had contributed to a spike in HIV and hepatitis C infections, as well as cases of thrombotic microangiopathy, a serious blood disorder.
The FDA’s action marked the first time the agency had requested the removal of an opioid from the market due to the public health consequences of abuse. In another effort to curb the nation’s opioid epidemic, the FDA is also planning to step up its opioid abuse education for prescribers, and regulation of packaging and dispensation methods for the drugs.