Purdue Pharma LP conducting children's trial of OxyContin
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.
"The generous incentives were made available to stimulate performance of studies necessary to provide useful information on drug use in children," Sandy Walsh from the FDA Office of Public Affairs explained by email.
Just today, the FDA issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone in order to protect the public from unsafe, ineffective and poor quality medications. Allowing Purdue to keep its exclusive patent on OxyContin -- which had more than $2.8 billion in sales in 2011, according to the Wall Street Journal -- would be incredibly beneficial to the company. The 2013 patent on OxyContin will expire before the study is completed, Heins said, but they have other patents on newer formulations of the drug that extend to 2025. He added that the six month extension would be added to the patents that expire in 2025.
Heins made it clear that Oxycontin was not approved for use in children, and Purdue does not advocate the use of the drug for minors. They are not seeking FDA approval for OxyContin for pediatric patients, but hope the study will provide more information about the effects of the drug on children.
"We're not trying to make a kid's version of Oxycotin," he told HealthPop by phone.
Currently, 17,000 of the 5.6 million Oxycontin prescriptions from June 2011 to May 2012 were for patients under the age of 19, according to CNN.
The FDA is especially interested in information about the effects of adult drugs like OxyContin on pediatric patients because children are rarely included in medical studies, Walsh said. Not only are kids smaller, their organs are still developing and they metabolize drugs in different ways. Just because a kid is half the size of an adult doesn't mean that half the dose will be appropriate. A recent FDA study showed that 50 percent of drugs do not have pediatric information on their labels.
"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."
But, some doctors are concerned about the effect the study could have on minors. Dr. Andrew Kolodny, president of the Physicians for Responsible Opioid Prescribing and a practicing psychiatrist in New York, told The Daily that he's concerned that children could become exposed to a lifetime of addiction.
"There's good medical evidence that suggests a brain that's not fully mature is at greater risk at developing the disease of addiction," Dr. Kolodny, who also serves as head of psychiatry at Maimonides Medical Center in New York, told The Daily.
Kolodny is also concerned that many in the medical community trust drugmakers, who might not be forthcoming with the effects of their drugs. Purdue admitted in 2007 that they misled doctors and the public about the additive effects of OxyContin.
"Much of that misinformation (came from a) campaign funded by Purdue," he explained.
But, Heins said that the fact that this is a clinical trial that follows FDA guidelines prevents any unnecessary abuse or misuse of the medications.
"These are clinical trial sites, not pill mills," he told HealthPop by phone. "So it's not mom and pop pharmacies that are involved in this but clinical trial centers."
Elliot Krane, director of pain management at Lucile Packard Children's Hospital at Stanford University and a participant in the study, told the Wall Street Journal he is confident that the study will help make OxyContin's use "more scientific and much safer." Dr. Krane, who has worked as a consultant previously for Purdue about the company's pediatric program, said he doesn't fear that children will start using OxyContin more because of the experiment.
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