The maker of OxyContin has announced it will study the safety of the painkiller in children, according to The Wall Street Journal. Purdue Pharma LP hopes the study will allow the company to gain six extra months of patent protection for the drug, the newspaper states.
The company will study the effects of two daily doses of OxyContin on more than 150 children ages 6 to 16 who have moderate to severe pain. If the study passes review by the Food and Drug Administration (FDA), the company will win a six-month extension on its patent for the original formulation of the drug, which is due to expire in April 2013.
According to the company, less than 0.3 percent of the 5.6 million OxyContin prescriptions written for the 12 months ending in May were for patients under age 19.
The FDA is encouraging drug companies to conduct pediatric trials, by offering to extend drugs’ exclusive manufacturing rights by six months. The agency wants to improve clinical data on the effects of medications on 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,” FDA spokeswoman Sandy Walsh told the newspaper.
Purdue Pharma is also arguing in court that a reformulated version of the drug may substantially decrease abuse of the opioid. The company spent $100 million to develop the new version of OxyContin. According to the company, the new formulation, introduced in 2010, is more difficult to abuse than the original pill. The patent on the new formulation extends to 2025. Several generic drug manufacturers are seeking to make their own versions of OxyContin, and Purdue Pharma has filed suits seeking to block those attempts.