Key Points:

i. FDA’s Decision: The FDA has opted not to approve MDMA-assisted therapy for PTSD, requesting further studies on its safety and efficacy.

ii. Impact on Psychedelics Movement: The decision represents a significant setback for the psychedelics industry, which viewed MDMA’s approval as a pivotal moment.

iii. Response from Lykos: Lykos Therapeutics plans to seek a meeting with the FDA and is disappointed by the need for an additional phase 3 trial.

iv. Support and Criticism: The treatment had strong support from patients and mental health advocates but faced opposition due to concerns about clinical research quality.

v. Future Outlook: Despite the setback, ongoing research and potential future approvals for other psychedelics like psilocybin may continue to advance the field.

https://summarynews.whatfinger.com/2024/08/10/fda-delays-approval-of-mdma-assisted-therapy-for-ptsd-setbacks-and-future-prospects/