The US FDA has approved the opioid oxycodone (OxyContin, Purdue Pharma LP) for pediatric patients aged 11 to 16 years with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

“We requested the manufacturer of the pain management drug OxyContin perform studies evaluating safety and other important information about oxycodone and OxyContin when used in pediatric patients. These studies supported a new pediatric indication for OxyContin in patients 11 to 16 years old, and provided prescribers with helpful information about the use of OxyContin in pediatric patients,” Sharon Hertz, MD, director, Division of Anesthesia, Analgesia, and Addiction Products, Office of New Drugs, at the Center for Drug Evaluation and Research (CDER), said in a “CDER conversation” posted on the FDA website.

Unlike adults, pediatric patients must already be responding to and tolerating a minimum opioid dose equal to at least 20 mg of oxycodone per day for 5 consecutive days before they can be prescribed an equivalent dose of OxyContin, Dr Hertz said.