The US Food and Drug Administration (FDA) has approved the use of the opioid OxyContin (oxycodone) for children aged 11–16 years whose pain is severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate.
The product will only be available if the child is already responding to and tolerating a minimum opioid dose equal to at least 20mg of oxycodone per day before they can be prescribed an equivalent dose of OxyContin, the FDA said.
The marketing approval is expected to benefit children being treated for cancer or recovering from extensive procedures, such as spinal surgery, it added.
Until marketing authorisation was given on 13 August 2015, OxyContin had only been available to children off-label, the FDA confirmed.
The product has been approved for paediatric use following paediatric use data supplied by its US manufacturer Purdue Pharma, which was made by the FDA under its Paediatric Written Request system. The FDA approval also requires Purdue Pharma to carry out post-marketing research that includes the collection of national prescribing data and three years of adverse event statistics.
OxyContin does not have a European Union (EU) wide marketing authorisation, the European Medicines Agency confirmed. However, medicines containing oxycodone, including OxyContin, can be authorised at national level in the EU, it said.
In the UK, OxyContin is available on prescription for adults but is not available for patients aged under 18 years, the Medicines and Healthcare and Regulatory Products Agency said.