FDA Panel Recommends Approval for Abuse-Deterrent IR Opioid

April 7, 2017

A joint US Food and Drug Administration (FDA) advisory committee has recommended that a new immediate-release (IR) opioid analgesic be approved and that labeling describe the product as deterring abuse via intranasal (IN) and intravenous (IV) routes.  The new product — oxycodone hydrochloride tablets with the proposed trade name RoxyBond (Inspirion Delivery Sciences LLC) — would be indicated for the management of moderate to severe pain where use of an opioid analgesic is appropriate.  If the FDA acts on these recommendations, the product would be the first approved IR opioid with abuse-deterrent properties.