The U.S. Food and Drug Administration has approved updated labeling for the reformulated painkiller OxyContin (controlled-release oxycodone hydrochloride). The new labeling will indicate that the drug has physical and chemical properties that make injection or snorting challenging. This new measure is designed to curb abuse of the drug.
The original OxyContin provides the same therapeutic benefits as the reformulated product, but has a greater potential for abuse. Consequently, the FDA has decided that the benefits of the original OxyContin no longer outweigh the risks and will not accept or approve new drug applications for generics that rely on the acceptance and approval of the original OxyContin.
The original OxyContin was approved in December 1995. Since then, the product has often been abused and manipulated in order to release the drug more rapidly, defeating its extended-release properties. This behavior is associated with serious risks, including overdose and death. In April 2010, a reformulated version entered the market and the original form was taken off the shelves by the manufacturer, Purdue Pharma, LP. By essentially banning generics based on the original drug, the FDA is hoping to cut down on dangerous abuse of this powerful opiate.
“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. “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 is expected to reduce abuse by snorting compared to original OxyContin.”
The new tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel that cannot easily be injected. While intranasal and intravenous administration of OxyContin is still possible, it is now more difficult. Oral abuse, however, is still feasible. The reformulated product is also intended to reduce incidents of therapeutic misuse. This includes crushing and sprinkling of the product onto food and administering it through a gastric tube.
When the FDA is presented with a new formulation that has abuse-deterrent properties, it has the authority to require generics to have these characteristics also. The impact of the reformulated OxyContin and generics is not yet known. The FDA will update its evaluation as new data become available.
The FDA, along with other public health agencies, encourages the development of abuse-deterrent forms of opiates to reduce prescription drug abuse. “At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics,” the agency stated. ■