Inability to chew Arymo ER tablet helps Egalet overcome questions about clinical meaningfulness of human oral abuse study results; advisors also back intranasal, intravenous deterrence claims.
The inability to chew Egalet Corp.'s Arymo ER (morphine sulfate extended-release) was enough to earn an FDA advisory committee's endorsement for an oral abuse-deterrence claim despite lingering uncertainty as to the clinical relevance of results from a human oral abuse study.
In a series of votes during an Aug. 4 meeting, the Anesthetic and Analgesic Drug Products and Drug Safety and...
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.
