U.S. health regulators have banned all generic versions of pain drug OxyContin, fearing they will be abused.
The decision comes as the U.S. Food and Drug Administration decided the therapeutics benefits of the original OxyContin no longer outweigh the risks due to the increased potential for it to be crushed up and snorted or injected to get high.
“The FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness,” the FDA said in a statement. “Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.”
Three years ago the health agency approved of a reformulated version of OxyContin that increases the risk of those adverse events. On Tuesday, it gave the nod to new abuse-deterrent labeling for the reformulated pain reliever.
The FDA approved of the original formulation in Dec. 1995 but the drug was quickly and widely abused, often following manipulation of the formula intended to defeat its extended-release properties. Its privately-held manufacturer, Purdue Pharma, stopped shipping the original version in 2010.
Without barriers to stop the immediate release, the drug’s properties are released more rapidly, which causes a high and the FDA said “the risk of serious adverse events” such as death and overdose.
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
While noting both versions of OxyContin are subject to misuse, he said the FDA believes the reformulated drug will make injection more difficult, expected to “reduce abuse by snorting compared to original OxyContin.”
The tablet is supposedly much more difficult to crush, break and dissolve than the original, it also forms a “vicious hydrogel” that health authorities say makes it difficult to prepare for injection. The FDA warns, though, that the abuse by these routes, as well as by taking too many pills orally, is still possible.
OxyContin was the top-selling pain drug in U.S. in the year ended June 2012, generating nearly $2.8 billion in sales, according to IMS Health. Pfizer’s (PFE) Lyrica was the second-best selling pain reliever last year with $1.8 billion in sales.