Oxycodone trial under way for children

August 1, 2012

One manufacturer of a patented oxycodone is now conducting a clinical trial that will evaluate the long-term safety of a daily 2-dose, controlled release formulation of the drug in children aged 6 to 17 years.

Oxycodone hydrochloride is increasingly prescribed off label for children with serious conditions that cause them to experience moderate to severe pain. One manufacturer of a patented oxycodone is now conducting a clinical trial that will evaluate the long-term safety of a daily 2-dose, controlled-release formulation of the drug in children aged 6 to 17 years.

The pediatric clinical trial is scheduled for completion in August 2013. The company plans to submit completed trial results with pediatric application to the US Food and Drug Administration (FDA) that effectively achieves an extra 6 months of patent protection for its name-brand version set to expire in April 2013.

Critics claim the company is conducting the trial to gain patent exclusivity, not merely to help doctors who currently prescribe oxycodone off label for children. They also worry that use of the powerful painkiller in children could lead to increased addiction and drug abuse, which already is a growing problem among adolescents.