A generic version of the painkiller Opana is set to hit the U.S. market at the start of the New Year after drug maker Endo Health Solutions Inc. (NASDAQ: ENDP) lost its bid to halt the release.
This week federal Judge Reggie B. Walton, of the U.S. District Court for the District of Columbia, dismissed a lawsuit by Endo against the Food and Drug Administration. Endo claimed the FDA failed to meet its legal obligation to determine whether the original formulation of Opana ER was withdrawn from the market for safety reasons.
Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone. Endo began selling Opana ER in 2006 and it quickly became one of the nation’s most widely abused opioid painkillers.
Endo launched a new version of Opana in March that is tamper resistant. It claims in court filings the original formulation is unsafe because the pills can be crushed and snorted by drug abusers. Endo was seeking a preliminary injunction to have the FDA suspend approval of the generic Opana, which is based on the original formula.
But the judge ruled against Endo, saying that he believes the FDA had not unduly delayed making a determination on the matter.
In its argument before the court, the FDA said it was not convinced that Endo was concerned with the health of drug abusers, since Endo had not recalled its original formulation of Opana ER. The FDA said the company’s insistence that the ganecy officially note the old version was withdrawn for safety reasons by December 31 was more a tactic to delay another generic company from entering the market.
“The December 31 deadline reflects only Endo’s commercial concern that, as a result of a settlement agreement it made with another manufacturer, it will face additional generic competition beginning January 1, 2013,” FDA attorneys wrote.
The judge’s ruling allows for a generic Opana that is not tamper resistant to enter the market on January 2, 2013. Impax Laboratories Inc. (NASDAQ: IPXL) and Actavis South Atlantic LLC are among producers of the generic Opana ER.
“We are extremely disappointed,” said Dave Holveck, president and chief executive officer of Endo. “Despite the fact that the generic product will not be therapeutically equivalent to the crush resistant formulation, the launch of a generic non-crush-resistant version of Opana ER in January will irreparably undermine the significant progress made in the reduction of abuse and misuse of oxymorphone.”
This battle over the release of generic versions of older opioid painkillers is similar to one waged last month when the Canadian Health Minister rejected pleas to delay approval of a generic form of OxyContin because it would trigger a new round of abuse and addiction.
Opana ER is prescribed for the relief of moderate to severe pain. A Schedule II controlled substance, it is physically addictive with side effects that include shallow breathing, slow heartbeat and seizures.