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The Food and Drug Administration April 16 said it approved updated labeling for Purdue Pharma LP's reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets.
The agency also said it will not approve any generics that rely on the older version of the pain drug.
According to the agency, the new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via snorting.
“Additionally, because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an 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FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness,” FDA said.
Because of this, FDA “will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.”
The agency noted that in reaching its decision, it reviewed citizen petitions requesting that FDA determine whether original OxyContin was voluntarily withdrawn from sale for reasons other than safety or effectiveness. In a Federal Register notice set for April 18 publication, the agency said the tablets approved under new drug application 20-553 “were withdrawn from sale for reasons of safety or effectiveness.”
FDA said it approved the original formulation of OxyContin in late 1995.
“The product was abused, often following manipulation intended to defeat its extended-release properties,” FDA said, adding that such manipulation “causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”
In April 2010, FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for misuse or abuse (8 PLIR 467, 4/9/10). Purdue stopped shipping original OxyContin to pharmacies in August 2010, the agency noted.
Douglas Throckmorton, deputy director for regulatory programs in FDA's Center for Drug Evaluation and Research, said in an agency statement that 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.” FDA noted that abuse of OxyContin by these routes, as well as the oral route, still is possible.
FDA said it determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve, the agency said, adding that it forms a “viscous hydrogel and cannot be easily prepared for injection.”
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 said.
“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,” the agency statement said.
FDA is taking other measures to address concerns about the abuse of pain drugs. In late March, an agency official said FDA will hold a public meeting at the end of September to seek input on its draft guidance for the development of abuse-deterrent opioids (11 PLIR 436, 4/5/13). In January, FDA issued a draft guidance to help industry develop new formulations of opioid drugs with the goal of preventing abuse (11 PLIR 46, 1/11/13).
A prepublication copy of the Federal Register notice about OxyContin is at http://op.bna.com/hl.nsf/r?Open=bbrk-96ts9g.
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