FDA Panel Rejects Intellipharmaceutics' Opioid For Missing Data, Blue Dye Safety Concern
Panel members question why company pursued filing for its oxycodone ER given lack of data; agrees with FDA that blue Gatorade consumption does not show safety of dye excipient used to deter abuse.
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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.
Four new pain drug formulations are heading to advisory committees in January. The meetings will also feature new FDA leadership in the pain/addiction review division following the retirement of Sharon Hertz.
Advisory committee notes missing pieces in sponsor's data for abuse-deterrent oxycodone extended release opioid; excipients to deter abuse also need toxicity testing.