Purdue Pharma L.P. announced that the U.S. Food and Drug Administration (FDA) has approved new language for the product label for OxyContin® (oxycodone hydrochloride controlled-release) Tablets CII that describes abuse-deterrence studies conducted with the reformulated tablets. Purdue’s press release said the company “is gratified that the FDA has determined that the original OxyContin extended release tablets were withdrawn from sale for reasons of safety or effectiveness. FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.”
An April 16 Bloomberg.com report noted, “The determination will keep generic drugmakers such as Teva Pharmaceutical Industries Ltd. (TEVA) and Impax Laboratories Inc. (IPXL) from making copies of the older version.” The article pointed out, “The patent expires today for Stamford, Connecticut-based Purdue Pharma’s original formulation of OxyContin.”
“Purdue Pharma is pleased with the FDA’s approval of this new language for the OxyContin label, which will provide important information to healthcare professionals,” said Gary L. Stiles, MD, senior vice president of Research and Development at Purdue Pharma L.P. “While the data from the abuse-deterrence studies have been included in the product label, OxyContin remains a Schedule II controlled substance and healthcare professionals should continue to exercise care in selecting and monitoring patients when prescribing OxyContin.” Full prescribing information for OxyContin® is available.
In its press release, “FDA approves abuse-deterrent labeling for reformulated OxyContin,” the agency noted the following, “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 the intranasal route (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FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. 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 formulation of OxyContin in Dec. 1995. The product was abused, often following manipulation intended to defeat its extended-release properties. 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, the FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for purposes of misuse or abuse. Purdue stopped shipping original OxyContin to pharmacies in August 2010.
“The FDA has determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be 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. However, abuse of OxyContin by these routes, as well as the oral route, is still possible. 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. 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.”