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.
You may also be interested in...
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.
US FDA Dives Back Into Opioid Reviews Under New Division Leadership
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.
What's Missing In Intellipharmaceutics' Opioid Filing? FDA Panel Offers List
Advisory committee notes missing pieces in sponsor's data for abuse-deterrent oxycodone extended release opioid; excipients to deter abuse also need toxicity testing.