FDA nixes generic OxyContin, approves abuse-deterrent labeling for reformulated OxyContin

FDA announced April 16 that it will not approve any generic versions of the original OxyContin formulation as the benefits no longer outweigh its risks. The original OxyContin was withdrawn from sale for reasons of safety, as it could be easily misused and abused by crushing and snorting. The original formulation was approved in 1995.

FDA approved updated labeling for reformulated oxycodone hydrochloride controlled-release (OxyContin, Purdue Pharma) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make misuse and abuse via injection difficult and to reduce abuse via the intranasal route.

“The recent FDA approval of the updated labeling . . . serves as a victory for both consumers and healthcare providers because increased incidences of overdoses and/or or death attributed to Oxycontin use was viewed by both sides as a public health concern that was quickly becoming an epidemic,” said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas. “By deterring potential abuse with the reformulated version of Oxycontin, countless lives may be saved while at the same time promoting the appropriate use of this medication.”

The original formulation of OxyContin 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 risks of overdose and death. In April 2010, 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.

FDA has determined that the reformulated product has abuse-deterrent properties, making it 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,” according to the statement.

FDA’s analysis included the review of citizen petitions that requested if the original formulation was voluntarily withdrawn from the market for reasons other than safety and effectiveness, public comments associated with these petitions, information about the withdrawal of the original formulation, and clinical data and peer-reviewed literature concerning the postmarketing adverse events associated with the original formulation, reformulated OxyContin, and other extended-release oxycodone products.

FDA is continuing to assess the impact of reformulated OxyContin and will update its evaluation of the effects of reformulated OxyContin on abuse as new data become available. The agency encourages the development of abuse-deterrent formulations of opioids and remains committed to providing access to opioid analgesics for patients with pain, the press statement said.