Safety concerns related to MDMA patient suggestibility and impairment troubled the panel reviewing psychedelic therapy for PTSD, although the FDA advised that therapist misconduct is outside its control.
Advisory committee members could not limit their review of Lykos’ proposed MDMA therapy for post-traumatic stress disorder to issues directly within the US Food and Drug Administration’s control, which could impact the agency’s final decision on the product.
Lykos’ proposed midomafetamine-assisted therapy (MDMA-AT) process poses a “novel treatment paradigm,” where the psychedelic drug is intended to catalyze effective...
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.
