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.

An FDA advisory committee voted 22-1 against approval of Intellipharmaceutics International Inc.'s opioid Rexista (oxycodone extended-release), finding the company had not conducted sufficient studies to support the safety and efficacy of the drug.

Intellipharmaceutics' 505(b)(2) application includes in vitro studies (Category 1), but not pharmacokinetic (Category 2) or clinical abuse potential (Category 3)...