RoxyBond Clears US FDA With Abuse-Deterrent Properties, But No REMS Yet

Inspirion's oxycodone is first immediate-release opioid approved with abuse-deterrent language in labeling.

Opioid abuse epidemic concept

The US FDA gave its blessing to Inspirion Delivery Sciences LLC's immediate-release (IR) opioid RoxyBond (oxycodone hydrochloride), making it the first IR opioid with abuse-deterrent language in the labeling, but the incorporation of a Risk Evaluation and Mitigation Strategy (REMS) could still be at least a few months away.

The company announced the approval of RoxyBond April 26 with the indication for the management of pain severe enough to...

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