OxyContin's new formulation approved by FDA

April 15, 2010

A reformulation of controlled-release oxycodone (OxyContin, Purdue Pharma), designed to curb misuse and abuse of the drug, has received FDA approval.

A reformulation of controlled-release oxycodone (OxyContin, Purdue Pharma), designed to curb misuse and abuse of the drug, has received FDA approval.

The new composition of the drug is designed to keep the opioid from being broken, chewed, crushed, cut, or dissolved to deliver more medication. The modified drug composition may lead to less risk of overdose related to tampering and may lead to less abuse through injection or inhalation of the substance. However, it can still be misused through use of the drug in greater doses.

The drug’s manufacturer is mandated to establish a post-market study to gather data on whether the new formulation reduces abuse and misuse of this opioid. The FDA also requires a REMS necessitating that providers give a Medication Guide to patients and that providers receive information about the proper use of opioid analgesics for treatment of pain.