The maker of the prescription painkiller OxyContin confirms that a clinical trial is currently underway to measure the opioid's effects in children.
Although doctors can prescribe OxyContin off-label to pediatric patients, the drug – which was overwhelmingly tested in adults - is not approved for use in children by the Food and Drug Administration, and Purdue Pharma says it is not seeking that approval.
To qualify for the study, patients must be between the ages of 6 and 17, have moderate to severe pain, and have already demonstrated a tolerance to opioid painkillers. The study will include 154 children.
"These children have diseases such as cancer or sickle-cell anemia, post-operative pain, injuries such as severe burns causing this degree of pain," said Jim Heins, senior director for public affairs at Purdue Pharma.
"The studies are evaluating the safety of OxyContin Tablets in these young patients and the way the drug is absorbed, broken down, and eliminated to see if there are any significant differences from the way the drug is handled by adults."
About 50% of drugs prescribed to children have no pediatric information on their labels, according to the FDA .
"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," writes the FDA on its website. "This effort ensures children are not denied therapies because we do not know how to properly dose or use them."
As an incentive, the FDA could grant Purdue Pharma a six month patent extension on its original OxyContin formulation in exchange for conducting the pediatric study, which is set to expire in April 2013. The extension would come only after the FDA receives the completed pediatric study, regardless of the outcome.
"Whether the results are positive or negative, we [Purdue Pharma] feel it is beneficial for clinicians who are treating pediatric patients with chronic, moderate to severe pain to have access to this information in scientific publications and in the product's label, so they can make better decisions about the care of their patients," said Heins.
The FDA has a long list of drugs approved for adults for which it is seeking pediatric studies. In 2010, Purdue Pharma updated its brand-name OxyContin with a new formulation intended to curb abuse, and that formulation has patent protections already in place until 2025.
In the past year doctors have written 5.6 million prescriptions for OxyContin, with only 17,000 of those prescriptions for patients under the age of 19.
Oxycodone, the main active ingredient in the brand-name drug OxyContin, also is not approved by the FDA for use in children. It also is on the list of drugs for which the FDA is seeking pediatric studies.
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