Purdue Pharma isn't counting on its aggressive patent litigation to extend its monopoly on OxyContin. It has a fallback plan. To qualify for 6 months' worth of extra exclusivity, Purdue is conducting a pediatric trial, testing the powerful painkiller in 150 children.
It's not unusual for a drugmaker to pursue that pediatric-exclusivity period. Pfizer ($PFE) did it with Lipitor, extending its hold on that market through November, rather than May of last year. And FDA obviously encourages drug studies in children, or there would be no incentive.
"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 The Wall Street Journal.
But because of OxyContin's notorious status as an addictive, routinely abused drug, Purdue's trial plans have stirred up criticism. Some doctors worry that the risk of addiction is greater in children, and that the pediatric trial will lead to increased use of OxyContin in kids--perhaps even to a label extension allowing Purdue to market the painkiller for pediatric use. The suspicion of hidden motives isn't altogether baseless; after all, the company did get into trouble with the feds for aggressively marketing OxyContin off label and downplaying its addiction risks.
Purdue says it's not looking for a pediatric indication on OxyContin. Only 17,000 pediatric scripts for OxyContin were written last year, less than 1% of the market, and the new study isn't expected to increase use in kids by much. The company doesn't need to grow pediatric sales for the study to pay off. An extra 6 months on its OxyContin monopoly could give Purdue an extra $1.4 billion in sales. The drug sold $2.8 billion worth last year.