FDA Refuses to Remove Generic Opana From Market

The agency rejected a request from the painkiller’s manufacturer to outlaw generic versions lacking tamper-resistant features just weeks after deciding the opposite way for generic versions of OxyContin.

The FDA has determined that generic versions of the painkiller Opana (oxymorphone) Extended-Release can remain on the market, rejecting a petition from Opana’s manufacturer, Endo Health Solutions. In announcing its decision on May 10, 2013, the agency also stated that a purportedly tamper-resistant version of Opana ER can be abused in a number of ways.

Endo had filed the petition to outlaw generic versions of Opana ER, which went on the market earlier this year, based on the rationale that they lacked these tamper-resistant features. The agency determined that, while the reformulated version of Opana ER has demonstrated increased ability to resist crushing, its extended-release features can be circumvented by cutting, grinding, or chewing.

In addition, the agency noted that the reformulated Opana ER can be easily prepared for injection, contrary to Endo’s claims. Indeed, there is some evidence that, compared with the original version of Opana ER, a greater portion of abuse with the reformulated version involves injection. The reformulated version also appears to be easily rendered snortable.

The FDA’s decision came just a few weeks after it decided the opposite way in blocking generic versions of the painkiller OxyContin (oxycodone) that lacked tamper-resistant features implemented by its manufacturer, Purdue Pharma, in 2010. As part of its stepped-up efforts to ensure that commonly abused drugs have effective tamper-resistant features, the agency released guidelines for manufacturers in March and has offered to work with manufacturers to put them into effect.