番茄社区

The FDA has issued new labeling information for OxyContin -- on the same day the patent on the original formulation expired, thus blocking potential generic versions of the original that do not have abuse-deterrent properties.

The new labeling indicates that the product "has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route," according to an FDA press release.

In the statement, the agency said it will not approve any abbreviated new drug applications for generics that are based on the original formulation.

In a press release, Purdue Pharma's senior vice president of research and development, Gary Stiles, MD, said the company is "pleased with the FDA's approval of this new language for the OxyContin label."

Purdue voluntarily withdrew the original OxyContin formulation from the market after the abuse-deterrent version became available in 2010.

In a statement, Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said the development of abuse-deterrent opioids is a "public health priority for the FDA."

"While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and [is] expected to reduce abuse by snorting compared to original OxyContin," Throckmorton said.

The FDA said it had determined that the reformulated product has abuse-deterrent properties, as the tablet is harder to crush, break, or dissolve, and forms a viscous hydrogel that prevents it from being prepared for injection.

Yet the agency warned that it is not completely abuse-proof, noting that the reformulated product can still be crushed and sprinkled into food or given through a gastric tube.

The agency has also determined that when it finds that a new formulation has abuse-deterrent properties, it has the authority to require generics to have abuse-deterrent properties as well.

“This is clearly a victory for Purdue, which continues to profit immensely from a drug they admitted to marketing illegally,” David Juurlink, MD, PhD, a drug safety researcher and internist at the University of Toronto, told 番茄社区.

Juurlink was referring to a 2007 court case in which Purdue executives pled guilty to false marketing and the company was forced to pay a $635 million fine.

An FDA spokesperson, however, did not comment on whether the agency would take action against generic versions of original Opana (oxymorphone), which started shipping in January after patents on original Opana expired. She said today's action specifically applies to OxyContin alone.

Opana drugmaker Endo Pharmaceuticals had sued the FDA to block generic versions of the drug, but the lawsuit was dismissed.

Although the FDA's decision has been informed by principles set forth in a draft guidance on creating abuse-deterrent products, an FDA spokesperson said, the agency is still reviewing comments on that document, which was released earlier this year.

Several makers of well known opioid brands, including Purdue and Endo, have actively been trying to deter generic versions of their drugs that lack tamper-resistant technology.

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