Children’s OxyContin Trial Underway
Purdue Pharma LP, maker of the popular painkiller OxyContin, is conducting a trial to test the effects of the drug in children with the hopes of receiving an extension to their patent by the Food and Drug Administration.
The study, which has been ongoing since November 2010, is looking at how the drug is broken down, absorbed and tolerated overall by children compared with adult. The company is also looking at whether the drug relieves pain in children the same way it does in adults, but stressed they will not be released a grape-flavored version anytime soon.
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"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 CBS News.
More than 154 patients are involved in the study, with more being recruited. The study specifically looks at children between the ages of six and 16 with "moderate to severe pain," including those with cancer, sickle-cell anemia or severe burns.
The study will conclude in August 2013, and if it is completed according to FDA standards, Purdue would be given a six-month extension on their drug patent, which prevents generic versions from being made.
"The generous incentives were made available to stimulate performance of studies necessary to provide useful information on drug use in children," Sandy Walsh, spokeswoman for the FDA, told CBS News.
Walsh also said the effects of these powerful drugs on kids are of importance, because children are rarely included in the studies. Not only are kids smaller, they metabolize drugs differently, which means the mechanism of action for a child may be different than that of an adult.
"One of FDA's top priorities is giving pediatricians and parents the same level of tested and researched information on drugs used to treat children that is required for drugs used to treat adults," Walsh stated. "This effort ensures children are not denied therapies because we do not know how to properly dose or use them. All of FDA's initiatives around pediatrics have aimed to get products that are used in children studied in children."
While there is always the concern of addiction from painkillers, Dr. Daniel Frattarelli, chair of the American Academy of Pediatrics' Committee on Drugs, told ABC News that understanding the effects on kids would lead to doctors making better decisions.
"Pain is a real thing, and it needs to be treated," he said. "I would be much more comfortable prescribing it [OxyContin] if I knew that well-done studies had been conducted and also that there was a way of minimizing addiction."
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