Psychedelic Community Reacts To FDA Committee’s Critique Of Lykos’ MDMA Studies [Clinical Leader]

This past week, an FDA advisory committee voted 9-2 to reject the validity of therapy-assisted MDMA clinical trials conducted by Lykos Therapeutics for the treatment of PTSD. The FDA does not have to side with a committee, but it often does. To get a sense of the psychedelic drug development community’s reaction, we posed the following question to some of its leaders across pharmaceutical companies, healthcare providers, and mental health advocacy groups.

Joseph Tucker, Ph.D., CEO, Enveric Biosciences

“The thematic challenges that came to light in the Lykos Adcomm largely focused around two elements, expectation bias and the delivery of the psychological therapy. These are difficult to separate from any therapy that induces hallucinations and/or requires psychotherapy in the treatment protocol but would likely be eliminated as concerns for the impending next generation of non-hallucinogenic neuroplastogens. Some speculate that these and other advantages of the non-hallucinogenic neuroplastogens could result in them displacing hallucinogenic psychedelics to become the predominant new entrant to neuropsychiatric medicine that emerges from the psychedelics field.”

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