FDA Affirms It Will Not Approve Any Generic Forms Of OxyContin Despite Patent Expiration

The Food and Drug Administration (FDA) announced Tuesday that it will not approve generic forms of OxyContin and that, going forward, it will only allow the production and sale of the 2010 form of the drug, which was specially designed to mitigate abuse of the pain killer.

The announcement came the same day OxyContin manufacturer Purdue Pharma's original form of the drug, first released in 1995, was set to expire.

"The product was abused, often following manipulation intended to defeat its extended-release properties," the U.S. agency stated in a press release. "Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death."

Key to the newer form of the drug is its ability to turn into a jellylike mass when crushed, which in turn makes it harder to snort or inject, though the U.S. agency admits abuse is still a possibility.

Purdue Pharma said in its own press release that it has "undertaken a series of epidemiological studies to evaluate in real world settings whether the changes made to OxyContin's formulation are resulting in a decrease in misuse and abuse and their consequences: addiction, overdose and death." Any results, it explained, are "being reported to the FDA on an ongoing basis" in addition to publication in peer-reviewed journals.

But, the company said, it doesn't stop there.

"Amongst multiple ongoing development projects intended to provide abuse deterrence are additional formulations of oxycodone, morphine and a once-daily formulation of hydrocodone bitartrate, which," the company said, "is in the final stages of clinical development and incorporates the same abuse-deterrence technology as reformulated OxyContin."

What's more, the company said they are currently working on increasing prescriber and patient education through additional labeling while "ensuring that these medications remain accessible for patients with moderate to sever, chronic pain" as far as is appropriate.

In all, the FDA said their decision was influeced by citizen pettions and their comments, information concerning original reformulated OxyContin and withdrawal of it, as well as clinical data and peer-reviewed literature.