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FDA Approves 'Abuse-Deterrent' Label for New Oxycontin

Posted: Apr 16, 2013 5:00 PM by E.J. Mundell

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TUESDAY, April 16 (HealthDay News) -- In an effort to help curb the epidemic of prescription painkiller abuse, the U.S. Food and Drug Administration on Tuesday said it is approving new labeling for a reformulated version of Oxycontin that its maker claims will be harder to abuse.

The agency also noted that the original form of the powerful painkiller has been withdrawn from the market because it is easier to abuse than the newer formulation.

"Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin," the FDA added in a news release issued late Tuesday.

Prescription painkiller abuse continues to be a major problem across the United States. According to a report issued in January by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), some 22 million Americans -- 2 percent of the population -- have misused prescription painkillers since 2002.

Oxycontin (oxycodone hydrochloride controlled-release) already has Schedule II status as a potentially harmful and restricted-access narcotic, based on an FDA review. In January, an agency advisory panel voted to move other hydrocodone-containing painkillers such as Vicodin and Percocet to the same status.

One other way to rein in rampant abuse of precription narcotics is to develop formulations that are more difficult to break down and abuse.

The original form of Oxycontin, first approved in 1995, "was abused, often following manipulation intended to defeat its extended-release properties," the FDA explained. "Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death."

The new, "abuse-deterrent" version was approved in 2010 after being developed by maker Purdue Pharma, and the company stopped shipments of the older version of Oxycontin to pharmacies in August of that year.

The new version is "more difficult to crush, break or dissolve," the FDA said, and it forms a thick, sticky gel that resists being used as an injection. It is also more difficult to manipulate the drug so it can be snorted, the agency said.

"The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube," the agency noted.

"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 the agency's news release. "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."

The FDA notes that postmarketing studies looking at the abuse potential of the new formulation are ongoing.

More information

Find out more about prescription painkiller abuse at U.S Centers for Disease Control and Prevention.

SOURCE: April 16, 2013, news release, U.S. Food and Drug Administration

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