The company that makes OxyContin has a good thing going, with lots of free PR from shows like Intervention and Justified and no exact generic equivalent to undercut its market share. But there are dark clouds on the horizon for the OxyContin brand, as its patent is set to expire in April. Now, in a ploy to extend that patent, the Oxy folks are going through the motions of pretending they actually care whether or not children can take the drug safely.
The Wall Street Journal reports that Connecticut-based Purdue Pharma LP is just now trying to enroll youngsters in a study to test whether or not OxyContin would be safe and helpful to kids ages 6-16 with “moderate to severe” pain. All this is described in documents reportedly filed with the U.S. National Institutes of Health.
Whether or not the study is successful, so long as it passes an FDA review, it would result in a six-month extension on the Oxy patent.
Given that the drug brought in $2.8 billion in sales in 2011, this test is worth at least $1 billion to Purdue.
The move by Purdue is remarkably similar to one attempted two years ago by Pfizer, which sought to extend — no pun intended — the patent on Viagra by saying that a low-dose version of the drug could be helpful to children with a very rare lung disorder.
Both are examples of drug makers exploiting FDA incentives that encourage and reward clinical drug trials. The FDA argues that, because clinical trials rarely include children, it is trying to help provide accurate information to doctors that may prescribe medicine to children that is normally intended for adults. To the drug companies, it’s just an easy way to score a patent extension.
A rep for the company admitted as much when he told the Journal, “These trials are not intended to promote the use of OxyContin in pediatric patients.”
Some doctors aren’t exactly thrilled with the idea that Purdue is planning to test OxyContin — one of the more addictive painkillers on the market — on children with chronic pain conditions.
Meanwhile, Purdue has already begun arguing in court that a 2010 formulation update intended to curb Oxy abuse should rightfully extend the patent through 2025. Obviously, the generic drug makers, who stand to profit when the patent expires, disagree.
OxyContin Trial Planned for Kids [WSJ.com]