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Makers of OxyContin want to test its safety on children

Filed July 6th, 2012 Laurie

The makers of the controlled painkiller OxyContin are seeking patent exclusivity on the drug for another six months because it wants to test the drug’s safety on children.

According to a Wall Street Journal report, Purdue Pharma LLP has petitioned the Food and Drug Administration seeking another half-year of preventing generic forms of its popular opioid analgesic drug OxyContin from flooding the market while it conducts experimentation of the drug’s safe use in children.

When a company loses patent exclusivity on a prescription drug, it immediately suffers a considerable downturn in sales as patients look for a less expensive alternative. Not everyone relies on generic drugs so sales do not necessarily plummet. Some pharmaceutical companies have offered generics manufacturers lump sums of cash in anticipation of it releasing a generic form of their name-brand drug to keep it off the market for a limited time.

Purdue Pharma has asked the FDA to extend the time it enjoys patent exclusivity while it conducts this latest safety review that could open an enormous market potential for it and future generic manufacturers of OxyContin. The company is seeking at least 150 participants aged 6 to 16 who are experiencing chronic moderate to severe pain to determine if OxyContin is safe for children.

OxyContin is considered a controlled substance and is one of the most abused prescription drugs worldwide. Children are already among those who are known to abuse this drug as it’s commonly more widely available to them than other “street” drugs.

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