The US Food and Drug Administration (FDA) today approved updated labelling for the abuse-deterrent formulation of oxycodone hydrochloride controlled-release tablets (OxyContin, Purdue Pharma LP).
The new labelling acknowledges that the product has physical and chemical properties that are expected to make abuse by injection or snorting more difficult.
"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 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."
In the same announcement, the FDA noted that because the original formulation has benefits similar to those of the reformulated version but poses increased potential for certain types of abuse, "the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety and effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin."
The FDA approved the original OxyContin in December 1995, but it was widely abused, usually after being crushed or dissolved to release the drug more rapidly. The rapid-release though increases the risk for serious adverse events, including overdose and death, the FDA release said.
The agency approved in April of 2010 a reformulated version of OxyContin designed to make it more difficult to manipulate, and Purdue stopped shipping the original formulation to pharmacies in August that year.
In this new announcement, the FDA says it has determined that the reformulated product has abuse-deterrent properties, making it more difficult to crush, break, or dissolve, forming a "viscous hydrogel" not easily prepared for injection. "The agency has determined that the physical and chemical properties of the reformulated product are expected to make the product difficult to inject and to reduce abuse via snorting."
These properties may also reduce therapeutic misuse of the product, such as crushing it to sprinkle onto food or administer through a gastric tube. However, abuse by these routes as well as orally is still possible even with the new formulation, the FDA adds.
"When FDA finds that a new formulation has abuse-deterrent properties, the agency has the authority to require generics to have abuse-deterrent properties also," they write.
Their review of this issue included citizen petitions requesting that the agency determine whether the original formulation was voluntarily withdrawn from sale for reasons other than safety or effectiveness; comment submitted to public dockets associated with those petitions; information on the original and reformulated products and withdrawal of the original OxyContin; and clinical data, peer-reviewed literature, and other information on post-marketing adverse events with both formulations and other extended-release oxycodone products.
Postmarketing assessments are ongoing, the statement adds, and the FDA's evaluation of the effects of the new formulation on abuse will be updated as new data become available.
"The FDA, together with other public health agencies, continues to encourage the development of abuse-deterrent formulations of opioids and believes that such products will help reduce prescription drug abuse," the FDA concludes. "At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics."
More information is available at the FDA site:
Federal Register Notice: http://www.ofr.gov/OFRUpload/OFRData/2013-09092_PI.pdf
FDA Actions on OxyContin Products:http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm347857.htm
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