Tuesday, April 6, 2010

U.S. FDA Approves New OxyContin Formulation

In The NewsThe U.S. Food and Drug Administration (FDA) just approved a new formulation of the popular controlled-release opioid pain reliever OxyContin®. The reformulated version is expected to help discourage misuse and abuse of the medication; although, caution is still needed by prescribers and patients.

Approved by the FDA in 1995 and manufactured by Purdue Pharma L.P., Stamford, CT, USA, the active ingredient in OxyContin is oxycodone, which slowly releases to treat patients who require around-the-clock medical management of moderate to severe pain with an opioid analgesic. Persons intent on abusing the previous formulation were able to release high levels of oxycodone all at once, contributing to high rates of abuse and potentially fatal overdose. There also were reports of inadvertent overdose with OxyContin after healthcare practitioners crushed the drug for administration to patients who could not swallow the tablet.

The reformulated version is intended to prevent immediate access to the full dose of oxycodone via cutting, chewing, or breaking the tablet. Furthermore, attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected. However, if administered in higher than recommended doses, the new formulation can still be abused or misused and result in overdose, so healthcare professionals need to remind their patients of the risks associated with using OxyContin not-as-directed. “Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” said Bob Rappaport, MD, of the FDA.

The FDA is requiring an “interim” REMS (Risk Evaluation and Mitigation Strategy) for this product that will include a Medication Guide for patients and required prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain. Purdue also is required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid.

> FDA Approves New Formulation for OxyContin [news release]. April 5, 2010 [
available here].
> FDA teleconference; April 6, 2010. Presentation by Bob Rappaport, MD, and staff.
More Information:
> OxyContin - Questions and Answers. April 5, 2010 [
available here].
> A Guide to Safe Use of Pain Medicine. February 23, 2009 [
available here].