Endo Pharmaceuticals on Thursday agreed to remove its long-acting Opana ER (oxymorphone hydrochloride) pain drug from the market, about a month after Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, requested that the company stop selling the product because of growing incidents of manipulation and misuse.
The controversy with Opana ER dates back to March, when an FDA advisory committee decided by an 18-to-8 vote that the benefits of the abuse-deterrent formulation of the product no longer outweighed its risks. Postmarket studies show individuals are still able to crush the tablets and inject the substance. Injection abuse of reformulated Opana ER also has been associated with a serious outbreak of HIV and hepatitis C, according to the FDA.
An outbreak of HIV in Indiana in 2015 was, in part, tied to misuse of Opana ER.
According to Endo, net sales of Opana ER were $158.9 million in 2016, and the company maintains that the long-acting pain drug has positive benefits and is safe when used as intended. Had officials not agreed to pull the drug, the FDA would have removed it from the market anyway by withdrawing approval.
Opana ER was first approved in 2006. Six years later, Endo replaced the original formulation with a new abuse-deterrent formulation intended to make the tablets resistant to physical and chemical manipulation for the purpose of misuse by snorting or injecting.
Separately, Gottlieb also scheduled a public meeting on July 10-11 to examine all opioid medications with abuse-deterrent properties.