Purdue Pharma LP conducting children's trial of OxyContin

OxyContin tablets are seen in Montpelier, Vt., in this July 19, 2001, file photo.

/ AP

(CBS News) 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.

"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.

[satvairic]

are you kidding? a company that gets the mew OP approved in a year in a half when all others it takes up to 5 years and for this reasson on the DFDA part was epidemic but to approve it with out checking out one of the ingredients that is called Bitrtrate wich this product is used i minding chemicals together one we all know is chewng gum how do ya think you can chew gum for ever,the other products is motercycle oil diesel ful and and buch of othe products on theses same very dangerous lines,it would not take Einstien to tell you that taking even small amounts of a product like this could me beyond dangoerous,,and ths product also is the very reason it reall dont work when taken as needed and if it breaks down in yer system with that strong of a binder i even had a friend thats on these say not to sound gross but saw one or 2 in his stool cuz of feeling a large bump while passing when he ate yougart that day made him look at his stool to ultimitly fing one that just went rite thru his system? so what does this new OP do to your body lets say 5 years like it should have took on the study before it was OK,by the FDA! Herion only came back to take its pace even cheaper in history and paying the outragious price for down rite Junk VS a genric Drug even if it is the old formula Drug,,, kid will find anything to be cool to their peers there on a sum sort of drug and now they are,even 10 times more dangerous than oxy,its them bath salts and fake weed you can walk into any gas station and buy as MUCH AS YOU WANT and on top of all this they Actuaully got the brass and are taken on a gift the FDA offered to any pharma company that did a study with pain meds on kids 6 ta 16 that is a gift of a 6 month exstenon on ther paten on that Drug,,are they doing these OP,a ans Study,s on babys for the good of people like they claim?...you got to know the answer already in yer mind...NOT ONE BIT!!! purdu Pharma brings in almost 3 billion a year on ther new OP junk and the old too wich are close to the same numbers so 6 more months of a compkete greedy move wich will net them 1.6 ta 2 billion for them 6 months and the thankful part they have no real intensions of selling that crap ta kids a Purdu spokes person said in a interview but wit h who knows,but i do say just Bring the genrics back fast old formuls ta stop these Robberies that really got huge after Purdu used their patents to stop Genrics and corner the market with that one drug,the real patients are the ones who really need them the most due to not know every time they take Purdu,s new Junk will even work for them on that dose or not and thats been provven if you could only see the complaint list they posted a few monthe Back in fact there were so many complaints somebody couldive gotton Elected for some kind of political Office?..so worried about abuse? dont worry something else will come along as always just like these did and people will move on to the next

[FormerUSMCSergeant]

"These trials are not intended to promote the use of OxyContin in pediatric patients..."
---
BS.

[lemur123456]

I HATE purdue pharma.

[Lifesablast]

Excellent idea. Turn them into addicts while they are still kids.
That way the patient will be a customer for life, although a short
life.

[Cyunvwyatt]

So they are making a billion dollars literally in the name of the children and their health we are going to give them Heroin! If the FDA approves this you know who just got paid!