July 4, 2012
Pharma Begins OxyContin Trials In Children
Lawrence LeBlond for redOrbit.com - Your Universe Online
Purdue Pharma, the maker of the widely-used, and equally-abused drug, OxyContin, is now looking to gain 6 extra months of patent protection with new clinical trials that could possibly see market of the drug to children.The patent on the potent painkiller is set to expire in 2013 and Purdue, following in the footsteps of other drugmakers that have pursued pediatric-exclusivity, is testing the drug´s potential for use in children in its fight to retain ownership of its formula.
Pfizer pursued pediatric-exclusivity last year with its drug Lipitor, extended patent protection from May to November. Such moves are actually encouraged by the US Food and Drug Administration (FDA), which supports drug studies in children.
“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,” agency spokeswoman Sandy Walsh told Timothy W. Martin at the Wall Street Journal.
Despite this, some see the move as controversial, particularly due to the high-addiction threat with OxyContin use, which belongs to a class of opioids such as morphine and heroin. Still, pain specialists say it is an important step in drawing a more accurate picture of the drug´s effect on children, considering that many physician´ already prescribed the drug off-label to kids.
Stamford, Connecticut-based Purdue Pharma will study the effects two daily doses of OxyContin have on more than 150 children ages six to 16 who have “moderate to severe” pain and require opioid analgesics, according to documents filed with the US National Institutes of Health.
Purdue emphasized, however, that it is not trying to make a child´s version of the drug, nor is it hoping to seek FDA approval for pediatric use of OxyContin. The goal, according to spokesman James Heins, is to provide more information on how the drug acts in the bodies of children who may need it for overwhelming pain due to cancer, sickle cell anemia, and other traumatic illness.
Purdue said pediatric indication on OxyContin is not its mission. Only 17,000 pediatric scripts were written for OxyContin last year, less than 1 percent of the market, and the new study isn´t expected to increase use in kids by much. It added that it doesn´t need to grow pediatric sales for the study to pay off. It noted that, what will pay off, is an added buffer zone -- six more months of patent protection, giving the company an extra $1.4 billion in sales (the drug earned Purdue $2.8 billion in 2011).
If the study passes FDA approval, the company will win that patent extension for its original formulation of OxyContin, which will expire in April 2013.
The trials are already underway across the country, and Purdue said it plans to continue them for up to four weeks. Once the trials are complete, the results will be sent to the FDA. Whatever the outcome of the study, Purdue expects to get the patent extension.
Drug trials at one time rarely included the effects of medical treatments on children. But over the past ten years, the FDA has offered incentives for drugmakers to conduct more pediatric trials, mainly in offering manufacturing rights by six months in most cases. These types of trials help inform doctors who are prescribing medications to children under “off-label” use, according to the FDA.
Yet the controversy continues to heighten.
Clinics that take money from Purdue and put children with chronic pain on OxyContin are unethical, argued Andrew Kolodny, president of the Physicians for Responsible Opioid Prescribing and a practicing psychiatrist in New York. “With children, we have to be more concerned for risk with addiction,” he said.
Elliot Krane, director of pain management at Lucile Packard Children's Hospital at Stanford University and a participant in the study, said the drug is reserved for children undergoing major surgery to the spine or chest and for cancer patients.
This study won't lead to a boost in youth usage, but rather “would make the use of the OxyContin more scientific and much safer,” noted Krane.
Dr. Daniel Frattarelli, chair of the American Academy of Pediatrics' Committee on Drugs, told ABCNews.com´s Carrie Gann that doctors face the challenge of balancing concerns about addiction with the need to treat pain in children. But, if OxyContin is going to be used in children, it must be studied in children.
“Pain is a real thing, and it needs to be treated,” he added. “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.”
Purdue said it inquired about a pediatric trial with the FDA before setting it up, according to the company spokesman. And the FDA also submitted a written request favoring a study. Purdue will win the extension regardless of the outcome, but still needs to complete the trials and pass through FDA review to get that extension.