The FDA has issued new abuse-deterrent labeling for reformulated OxyContin on the same day the patent on the original formula expired, and has blocked potential generic versions of the original drug that lack abuse-deterrent properties.
The new labeling states the product “has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route.”
The FDA also indicated it will not approve any abbreviated new drug applications for generics based on the original formulation.
Since OxyContin was first approved in 1995, the FDA became aware that individuals were tampering with the medication to defeating its extended release properties and release the drug more rapidly. Reports of overdose and death prompted officials to approve a reformulated version in 2010 that is more difficult to manipulate for misuse and abuse.
Reformulated OxyContin has several unique features, including properties that make it harder to crush, break, or dissolve, and a property that causes the drug to form a viscous hydrogel to prevent it from being prepared for injection.
“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,” Douglas Throckmorton, MD, deputy director of regulatory programs at the FDA’s Center for Drug Evaluation and Research said in a statement.
Drug maker, Purdue Pharma, voluntarily withdrew the original OxyContin formulation when the tamper-resistant version became available. In a press release, the company’s senior vice president of research and development, Gary Stiles, MD, said he is “pleased with the FDA’s approval of this new language for the OxyContin label.”
Despite these safeguards, therapeutic misuse is still possible by crushing the drug and sprinkling it onto food or administering the medication through a gastric tube, the FDA warned. However, the agency asserted it’s authority to require generics to adopt innovated abuse-deterrent technology as it becomes available in new formulations.