U.S. health regulators announced on Tuesday that they will not approve any generic versions of the original form of the pain medication OxyContin, which was widely abused because it could be crushed and then snorted or injected to produce a quick high.
At the same time, the Food and Drug Administration also approved new labeling for a reformulated OxyContin, which was introduced by privately held manufacturer Purdue Pharma L.P. in 2010. The label will indicate that the tablets' physical and chemical properties make them more difficult to crush, meaning that abuse is less likely than with the original.
In a statement, Republican Representative Hal Rogers of Kentucky, a state with a high level of OxyContin abuse, called the FDA decision not to approve generic OxyContin "a huge win for our region and for the thousands of families who have seen painkillers become pain makers. The FDA undoubtedly saved our nation from another deadly tidal wave of oxycodone abuse and overdoses" which might have resulted from the introduction of generic forms of the original, crushable OxyContin.
Oxycodone hydrochloride is the chemical name of the drug, which is sold under the brandname OxyContin. Without competition from generics, the price of the painkiller is not likely to decrease.
Earlier on Tuesday, Rogers took to the floor of the House of Representatives urging the FDA and commissioner Margaret Hamburg to take immediate action to keep the easily abused form of OxyContin, including any generic versions, from being sold again.
The FDA approved the original formulation of OxyContin in 1995. Although the medication was manufactured in a way to release the pain-killing drug over an extended period of about 12 hours, cutting or crushing the tablets defeated those extended-release properties and produced a fast, powerful high when snorted, injected or even sprinkled on food. OxyContin became known as "hillbilly heroin."
That abuse, the FDA said, increased "the risk of serious adverse events, including overdose and death."
In April 2010, the FDA approved a reformulated version of OxyContin, designed to resist abuse: instead of becoming a fine, snortable powder when crushed or broken, it turns into a gummy sludge - what the FDA calls "a viscous hydrogel" - that cannot be easily snorted or injected like the original. Purdue stopped shipping original OxyContin that August.
The withdrawal, the FDA concluded, was "for reasons of safety or effectiveness." Under federal law, that allows the agency to refuse to accept applications from generic version of oxycodone hydrochloride that rely on the FDA's approval of original OxyContin.
"Purdue is gratified that the FDA has determined that the original OxyContin extended release tablets were withdrawn from sale for reasons of safety or effectiveness," the company said in a statement.
"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."
When the FDA finds that a new formulation of a drug has properties that make abuse more difficult, it has the authority to require generics to have abuse-deterrent properties as well.
The agency is continuing to monitor the impact of reformulated OxyContin on abuse.