July 3, 2012— -- The maker of the powerful pain drug OxyContin is beginning to test the medicine in children, hoping to secure an extra six months of protection for the drug's patent, which is set to expire in 2013.
The move is controversial, in light of problems with addiction to OxyContin, which belongs to the family of drugs called opioids that also includes morphine and heroin. But several pain specialists say the move is an important step in giving a more accurate picture of the drug's effect on children, considering that many doctors already prescribe the drug off-label for children.
OxyContin's manufacturer, Purdue Pharma, emphasized that the company is not trying to make a kid's version of the drug, nor is it hoping to seek the U.S. Food and Drug Administration's approval for pediatric use of OxyContin. The goal, said company spokesman James Heins, is to give more information on how the drug acts in the bodies of children who may need it for the overwhelming pain of conditions such as cancer, sickle cell anemia, severe burns and other trauma.
"Doctors are already prescribing it in limited cases for kids, but they don't have the benefit of any clinical studies showing how these drugs work in kids. Right now, all they have to go on is data from adult patients," Heins said.
The trials are already underway across the country, and Purdue hopes to enroll 154 children from ages 6 to 16 who would take the drug for four weeks. When the trial is complete, the company will send the results to the FDA. Whatever the outcomes of the study, Purdue will get an extra six months of patent protection for their trouble. OxyContin earned Purdue $2.8 billion in 2011.
The trial may seem to be centered in financial gain, and experts said the company is likely moved in large part by financial incentives. But Dr. Joseph Tobin, professor and chair of anesthesiology at Wake Forest University School of Medicine, said if drug companies are not given financial incentives to test drugs in pediatric populations, the studies would not get done at all.
"Children have become therapeutic orphans in the development or testing of new drugs. The expense and the risk are high, but the profit margin to be obtained is small compared with other diseases," Tobin said. "I think it's essential that this type of process goes forward so we can get better information on the safest uses of drugs in children."
In 2002, the government attempted to give drug companies incentives to test their medicines in kids with the Better Pharmaceuticals for Children Act, a law that allows an additional six months of patent protection for on-patent drugs. The patent that would be extended for Purdue would be the one covering OxyContin's formulation, which was modified in 2010 to make it harder for people to misuse and abuse the drug.
One of the drug's patents that will expire in 2013 is the one covering OxyContin's controlled release mechanism, which allows one pill to steadily dole out the medication over an extended period of time.
That mechanism is also what makes OxyContin different from other pain drugs, such as morphine and meperidine, or Demerol. It makes the drug more effective at treating pain, but it also makes it a highly attractive target for people addicted to opioids.
"The reason OxyContin has been such a social problem is that it locks up a large amount of drug in a small pill," said Dr. Elliot Krane, director of the pediatric pain management program at Lucile Packard Children's Hospital at Stanford University.
Health officials have become increasingly concerned about rapidly rising rates of painkiller addiction in the U.S. In 2010, a study funded by the National Institute of Drug Abuse found that 2.1 percent of 8th graders, 4.6 percent of 10th graders, and 5.1 percent of 12th graders had abused OxyContin for nonmedical purposes. The U.S. Centers for Disease Control and Prevention reported in 2011 that 40 people die per day from overdoses of painkiller medications like OxyContin.
Giving such a highly addictive and abused drug to children is controversial to be sure, and doctors say it will mean that prescribers must be particularly vigilant in watching how the drug affects young patients and to guard against pills being diverted to others to fuel addiction.
Krane, who is participating in Purdue's OxyContin trial and was a paid consultant for the company until last year, said the potential for children to become addicted to the drug is no greater or less than it is with other opioids that doctors give to children, such as morphine.
"Mere exposure will not turn them into an addict," Krane said.
Dr. Daniel Frattarelli, chair of the American Academy of Pediatrics' Committee on Drugs, said doctors face the challenge of balancing concerns about addiction with the need to treat pain in children. But he said 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," Frattarelli 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."