Medication Monitor

Generic Name (Trade Name—Company)
August 20, 2015

Extended-release oxycodone

(OxyContin—Purdue Pharma)
Opioid now approved for pain management in children aged 11 to 16

FDA has approved the use of extended-release oxycodone for long-term pain management in children aged 11 to 16 years old. The opioid is intended for pediatric patients whose pain has not responded to alternative treatments.

Approval for the new indication was based on manufacturer-conducted studies on the safety of extended-release oxycodone and its pharmacokinetic profile in pediatric patients, according to FDA. The painkiller can only be prescribed to children who already tolerate at least 20 mg/d of oxycodone or its equivalent.

Extended-release oxycodone was reformulated in 2010 to make the drug more difficult to abuse.