PTSD Therapy Denied by Advisory Committee

The application of MDMA-assisted treatment for PTSD was denied by a separate advisory council for the FDA, which expressed doubts about the validity of clinical trial results and came to the conclusion that the potential hazards did not exceed the advantages. Crucially, the FDA is not required to abide with the committee’s advice.

In February, the FDA approved the midomafetamine capsules NDA. The medication is supposed to be utilised in conjunction with psychological therapies including psychotherapy along with additional assistance for those with PTSD. Review of the application was given precedence.

The New York Times reported that panellists queried Lykos Therapeutics’ two presented experiments’ designs, citing in particular the reality that most people in the trials were able to accurately determine if they had taken MDMA or a placebo. The drug’s possible impact on the cardiovascular system as well as potential prejudice among the therapists and facilitators working with research participants were other concerns raised by the panellists.

Additionally, the panellists expressed great worry over the dearth of information from research subjects about the possibility of substance abuse.