Trials for psychedelic drug candidate for PTSD under scrutiny by FDA - report

seekingalpha08-24

The U.S. FDA has been conducting interviews with several individuals familiar with clinical trials conducted by Lykos Therapeutics for its rejected MDMA-based PTSD therapy as it investigates potential...

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The Wall Street Journal reported that at four individuals have been interviewed about the possibility some side effects -- including suicidal thoughts -- were not reported.  The newspaper noted that one person interviewed was asked about the techniques used in giving the therapy, called midomafetamine. Earlier in August, the FDA issued a Complete Response Letter to Lykos on the drug and asked the company to conduct an additional trial. Less than a week later, Lykos said it would lay off 75% of its workforce. Publicly traded psychedelic-focused drug developers include Mind Medicine , Atai Life Sciences , COMPASS Pathways , Cybin , and GH Research . 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