The U.S. Food and Drug Administration have banned generic drug manufacturers from producing versions of the old crushable form of OxyContin, in a bid to curb prescription painkiller abuse.
"The FDA has determined that the benefits of original OxyContin no longer outweigh its risks," the agency said in a statement released Tuesday.
The move represents a victory for OxyContin's manufacturer, Purdue Pharma, which in 2010 introduced a formulation of the drug that was less prone to tampering.
OxyContin was first approved in 1995. The drug gained popularity among prescription drug abusers who crushed the pill in order to snort it, or melt the pill to inject it. OxyContin tablets have a time-release formula that delivers the drug over a 12-hour period. But when a pill is crushed, the entire dose is immediately absorbed into the bloodstream.
However, the new reformulated pills make the drug more difficult to inject or snort, according to the FDA. The agency has approved new labeling for the drug that makes it clear the pills are more difficult to abuse. Any generic version of OxyContin that is submitted for approval should be based on this formula, the FDA says.
Douglas Throckmorton, MD, deputy director for regulatory programs for the FDA's Center for Drug Evaluation and Research, said: "The development of abuse-deterrent opioid analgesics 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 expected to reduce abuse by snorting compared to original OxyContin."
