OxyContin maker Purdue Pharma is testing its potent painkiller on pediatric patients to see how the drug works in children. If the clinical trial meets federal guidelines, the company could receive an extension on its patent.
The study is designed to see how OxyContin is absorbed, broken down, and eliminated in children compared to adults, and to see if the medication relieves pain in children as well as it does in adults. Researchers say that just because children are smaller, one shouldn’t assume that giving smaller doses will have the same effect in children as adults. Kids’ organs are still developing and they metabolize drugs differently.
OxyContin is not currently approved for use in pediatric patients, and Purdue says it does not intend to seek approval for use in children. The study’s goal is simply to provide more information about the effects of the drug in children.
OxyContin is a powerful time-release form of oxycodone that works by changing the way the brain and nervous system respond to pain. Generally, it is taken twice a day, a benefit over other painkillers that have to be taken several times a day.
OxyContin is prescribed to treat people with chronic pain, such as back and neck pain, as well as for cancer patients. The drug has become one of the most abused prescription drugs in the United States, which is the basis for criticism of the drug trial in children.
The OxyContin study was prompted by a “written request” by the Food and Drug Administration (FDA) asking for pediatric studies on oxycodone. If the agency’s requirements are met, the FDA and Congress may grant Purdue a six-month extension on its exclusive drug patent, protecting the company’s revenue share from generic drug makers. In 2011, OxyContin generated about $2.8 billion in sales for Purdue.
The pediatric study has been ongoing since November 2010, and focuses on children between the ages of 6 and 16 with moderate to severe pain who are treated with around-the-clock opioid medications. The trial includes children who suffer from cancer, sickle-cell anemia, post-operative pain, or injuries such as severe burns.
About 17,000 prescriptions written for OxyContin between June 2011 and May 2012 were for patients under the age of 19.
Source: CBS News