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)...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
