OxyContin manufacturer Purdue Pharma LP is currently undergoing a pediatric trial of the powerful painkiller to find out the effects of the drug on children, with the hopes of receiving an extension on the company's patent from the U.S. Food and Drug Administration (FDA).
The study takes a look at the safety of OxyContin tablets and how the drug is absorbed, broken down, and eliminated compared to adults. The company is also looking at if the drug relieves pain in children as well as it does in adults. News of the trial has prompted criticism of the motives behind testing the painkiller in kids.
"These trials are not intended to promote the use of OxyContin in pediatric patients but will provide clinical information about the product's pharmacokinetics, safety and to a lesser extent efficacy, in pediatric patients to clinicians who may be, or may consider, using the product in children with moderate to severe chronic pain," James Heins, senior director of public affairs for Purdue, told HealthPop by email.
The study, which has been ongoing since November 2010, specifically looks at children between the ages of six to 16 with "moderate to severe pain" who are being treated with around the clock opioid medications. Heins said this includes children who suffered from cancer, sickle-cell anemia, post-operative pain or injuries such as severe burns causing this degree of pain.
One hundred fifty four patients have been enrolled at more than 80 different locations, with more subjects currently being recruited. Patients will receive at least a 20-mg daily dose of oxycodone for at least two weeks. The study will conclude in August 2013.
If the Purdue's study is completed within the FDA requirements, the pharmaceutical company will be given a six-month extension on their exclusive drug patent due to an incentive from the FDA and Congress. The FDA currently has a "written request" for pediatric studies for oxycodone. The extension is granted to companies that complete a study in response to a written request, and if the study is determined by the FDA to meet all the items asked for in the request