Expert Reacts to FDA Committee Meeting Arguments on MDMA for PTSD I Boadie Dunlop, MD Insights 

In less than a month from now on August 11, 2024, the FDA will make their final decision on Lykos Therapeutics’ New Drug Application for MDMA-assisted psychotherapy to treat adult PTSD.
Last month, the FDA Psychopharmacologic Advisory Committee met and voted 2 - 9 against supporting the effectiveness of MDMA to treat adults with PTSD. HCPLive spoke with expert and vested stakeholder in the space, Boadie Dunlop, MD, professor of psychiatry and behavioral sciences at Emory University School of Medicine, regarding arguments the committee said during the meeting. Arguments included the safety and cardiovascular implicative risks of MDMA, as well as the inability to complete functional blinding.
“The idea that the efficacy measures of a drug should be discarded, thrown out because there's functional blinding threatens a lot of what these drugs in psychedelics and MDMA can offer, and we are seen to be holding it to a higher standard or a new bar compared to past drug approvals,” Dunlop told HCPLive.
Read more:
Part 1 (reactions to the meeting): www.hcplive.co...
Part 2 (thoughts on the future of MDMA): www.hcplive.co...
Key Time Stamps
Overall reactions to the meeting: 00:07
Thoughts on Functional Unblinding Discussion: 00:47
Safety of MDMA: 4:40
Potential misuse of MDMA: 6:18
#MDMA #PTSD #Lykostherapeutics #fda