April 24, 2013
FDA Won’t Approve Generics for Original Oxycontin;
OKs Reformulated Label

Washington, D.C.—The FDA has accepted updated labeling for reformulated Oxycontin tablets—which will now include the product’s abuse-deterrent properties—while also indicating that no generic forms of original Oxycontin will be granted approval.

The new labeling for reformulated Oxycontin, oxycodone hydrochloride controlled-release, says that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route.

In an announcement on the day the original OxyContin patent expired, FDA noted that the drug provides the same therapeutic benefits as reformulated OxyContin but poses an increased potential for certain types of abuse. Because the benefits no longer outweigh its risks, according to the regulators, original OxyContin was withdrawn from sale for reasons of safety or effectiveness. As a result, FDA said it will not accept or approve any abbreviated new drug applications that rely on the approval of original OxyContin.

The original formulation of OxyContin got the nod from the FDA in December 1995. Abuse of the product—which often includes manipulation to bypass its extended-release properties—increases the risk of serious adverse events, including overdose and death. Purdue Pharma LP reformulated the product, receiving FDA approval for the new version in April 2010, and stopped shipping the old formulation to pharmacies in August of the same year.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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.”

According to the FDA, the reformulated tablet is more difficult to crush, break, or dissolve and also forms a viscous hydrogel that cannot be easily prepared for injection and is harder to snort. The agency warns, however, that abuse of OxyContin is still possible by these methods or by swallowing the pills.

As a side benefit, the reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle onto food or to administer it through a gastric tub, the FDA added.

In a press release, Purdue Pharma said it was “gratified” by the FDA decision on generic versions of its original product and “pleased with the FDA’s approval of this new language for the OxyContin label, which will provide important information to healthcare professionals,” according to Gary L. Stiles, MD, senior vice president of Research and Development.

“While the data from the abuse-deterrence studies have been included in the product label,” Stiles pointed out, “OxyContin remains a Schedule II controlled substance and healthcare professionals should continue to exercise care in selecting and monitoring patients when prescribing OxyContin.”

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