A new formulation of OxyContin approved by the US Food and Drug Administration (FDA) is designed to discourage abuse and misuse of the controlled-release painkiller.
The reformulation makes it harder to release high levels of the powerful opioid by cutting, breaking, chewing, crushing, or dissolving it. The previous formulation led to high levels of abuse and misuse of OxyContin when it was crushed and snorted or injected. OxyContin was designed to bring patients with moderate to severe pain continuous pain control by releasing slowly over an extended period.
While the new formulation may prevent some overdoses and abuse, it can still be taken in larger doses than recommended, the FDA said in a press release.
“Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain,” said Bob Rappaport, MD, of the FDA’s Center for Drug Evaluation and Research.
The FDA is requiring OxyContin’s manufacturer, Purdue Pharma, to study whether the new formulation reduces abuse and misuse of the opioid. Purdue also will be required to issue a medication guide to patients and educate prescribers on the appropriate use of opioids for treatment of pain.