Abuse-Deterrent Labeling Approved for Reformulated OxyContin
FDA also announced it will not approve generics to the original formulation of OxyContin.
The U.S. Food and Drug Administration has approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets that indicates the product has physical and chemical properties to make it more difficult to abuse, either by injection or snorting it.
"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FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.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 agency's announcement stated.
The original formulation was approved in December 1995, and FDA approved a reformulated version in April 2010. The announcement said Purdue Pharma stopped shipping original OxyContin to pharmacies in August 2010. "The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," said Dr. Douglas Throckmorton, deputy director for regulatory programs in 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."
The reformulated product's tablet is harder to crush, break, or dissolve, and it also forms a viscous hydrogel and cannot be easily prepared for injection.