The rejection by the F.D.A. signals greater uncertainty for psychedelic medicine and highlights issues in the clinical trials that Lykos conducted concerning MDMA.
Lykos Therapeutics had been banking on F.D.A. approval of MDMA for PTSD treatment, but their application was rejected amidst concerns over trial integrity.
With the retraction of three papers by Psychopharmacology due to unethical conduct, the landscape for MDMA research has shifted drastically, calling for cultural changes in research.
MDMA has long been considered a potential breakthrough for PTSD treatment; however, the recent events have challenged the credibility of associated clinical research.
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