Most advisory committee members say Endo’s reformulated long-acting opioid no longer has a favorable risk/benefit profile due to increased intravenous abuse; panelists split on whether drug should be taken off market or if restrictive REMS would suffice.
Endo Pharmaceuticals Inc.’s reformulated Opana ER (oxymorphone extended-release) should either be removed from the market, or its prescribing limited through new labeling and a strict Risk Evaluation Mitigation Strategy (REMS), due to concerns about increased intravenous abuse of the long-acting opioid, US FDA advisory committee members said March 14.
Eighteen of 27 members of the Drug Safety and Risk Management and the Anesthetic and Analgesic Drug Products advisory committees...
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.
