FDA approves paediatric indication for Oxycontin (oxycodone) to treat severe pain- Purdue Pharma

The FDA has approved the opioid oxycodone OxyContin from Purdue Pharma LP for paediatric patients aged 11 to 16 years with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The FDA requested the manufacturer of the pain management drug OxyContin perform studies evaluating safety and other important information about oxycodone and OxyContin when used in paediatric patients. These studies supported a new paediatric indication for OxyContin in patients 11 to 16 years old, and provided prescribers with helpful information about the use of OxyContin in paediatric patients. Unlike adults, paediatric patients must already be responding to and tolerating a minimum opioid dose equal to at least 20 mg of oxycodone per day for 5 consecutive days before they can be prescribed an equivalent dose of OxyContin.

The warnings and precautions for paediatric patients taking this drug are the same as for adults.The FDA will require Purdue Pharma to conduct postmarketing studies aimed at assessing the safe use of the product in children.

Comment: OxyContin has had a chequered history – and was once called the "hillbilly heroin" in some parts of the US because of its excessive abuse. Purdue developed a reformulated version of the drug aimed at preventing abusers from cutting, breaking, chewing, crushing or dissolving the narcotic to attain an immediate euphoric high and the FDA approved the new OxyContin in August 2010, and in April 2013, Purdue became the first company permitted to include language describing abuse-deterrence in the labelling of a drug.

Oxycontin is marketed in the EU by MundiPharma and in the UK by Napp Pharma.