FDA OKs Pediatric Version of Purdue’s OxyContin

The US Food and Drug Administration (FDA) has approved a pediatric extended-release dosing for certain children age 11 to 16 for Purdue Pharma’s OxyContin (oxycodone), an opioid medicine used for pain management.

Sharon Hertz, M.D., director, Division of Anesthesia, Analgesia, and Addiction Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA. explained in an FDA website posting the rationale of the agency in approving the pediatric dosing for the drug. “To give healthcare providers more information on the safe use of drugs in pediatric patients, FDA can use its authority to ask manufacturers of drug products to conduct studies to obtain pediatric-specific information. 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.”

In adults, OxyContin is approved for the management of pain that is severe enough to require daily, around-the-clock, long-term opioid treatment. The FDA recently approved the use of OxyContin in certain pediatric patients 11 years and older. Similar to adults, OxyContin is approved for use in these patients to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. “The major difference is that all pediatric patients that are considered for pain management with OxyContin should already have been treated with an opioid pain medicine,” explained Hertz. “This way, their healthcare providers know that these pediatric patients can be treated safely with OxyContin.”

She pointed out that there are not many extended-release, long-acting products specifically approved for pediatric use. Duragesic (fentanyl) and OxyContin are the only extended-release opioid products with FDA-approved labeling regarding pediatric use. She added that there are also some immediate-release opioid medicines that have some pediatric information in their labels.

She said that the program to evaluate Oxycontin in pediatric patients was to address a knowledge gap in pain management. ” I must stress that this program was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients,” said Hertz. “Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients. This program was intended to fill a knowledge gap and provide experienced healthcare practitioners with the specific information they need to use OxyContin safely in pediatric patients.

Source: FDA (Hertz comments) and FDA (pediatric dosing approval)

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