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FDA allows sales of generic Opana painkiller to continue

U.S. rejects a request by drug firm, which said a new version would deter abuse, to halt sales of old versions.

May 10, 2013|By Lisa Girion, Los Angeles Times

Federal regulators said Friday that they would continue to allow sales of generic Opana, a narcotic painkiller similar to OxyContin, even though the pills are prone to abuse.

Like OxyContin, Opana is an extended-release narcotic designed to offer pain relief over several hours. When extended-release pills can be crushed, they are popular among addicts who snort the powder or liquefy and inject it, releasing the full dose at once.

In response to growing criticism of its widely abused OxyContin, Purdue Pharma introduced a tamper-resistant formulation in 2010. Last month, the U.S. Food and Drug Administration, in response to a request from Purdue, agreed to keep generic copycats of the old OxyContin off the market.

Endo Pharmaceuticals, which makes Opana, followed suit and introduced a new version of Opana that the company said would deter abuse. Endo also asked the FDA to halt sales of generic versions of the old Opana.

But on Friday, the FDA said that Endo's reformulation was not significantly safer than the original version.

"Reformulated Opana ER can be readily prepared for injection, despite Endo's claim," the FDA said. "It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods."

As a result, the FDA ruled, sales of generic versions of old Opana could continue. In January, California-based Impax launched the first generic version of old Opana; two other companies have applications pending to do the same.

The FDA indicated, however, that in the future, it would look favorably on new drugs that have a demonstrable edge in safety.

"FDA continues to encourage the development of abuse-deterrent formulations of opioids to help reduce prescription drug abuse and to positively affect public health," it said.

Sgt. Steve Opferman, who heads a prescription drug task force for the Los Angeles County Sheriff's Department, predicted that the FDA's decision would fuel popularity of the generic form of Opana on the street.

"Give it a few months and the data will speak for itself," he said.

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