Intellipharmaceutics’ Oxycodone ER Returns To US FDA Panel Looking For Abuse-Deterrence Claim
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.
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Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
How to score adverse events for Durect's surgical pain treatment could determine whether US FDA advisory committee recommends bupivacaine extended-release solution; agency questions whether Posimir's formulation may cause neurological adverse events.
Agency’s briefing document for 15 January review of the fixed-dose product combining an opioid and nonsteroidal anti-inflammatory reflects application of opioid benefit/risk framework described in June draft guidance.