Loading...
Market
What will be the outcome of the additional Phase 3 study for MDMA-assisted therapy for PTSD by March 31, 2025?
3
Resolution / Starting Odds
Study shows significant positive results • 25%
Study shows moderate positive results • 25%
Study shows no significant effect • 25%
Study shows negative results • 25%
Lykos Therapeutics official announcements and clinical trial registries
Story
FDA Rejects MDMA for PTSD Treatment, Requests More Research
Aug 9, 2024, 09:21 PM
The U.S. Food and Drug Administration (FDA) has rejected the application for the use of MDMA-assisted therapy to treat PTSD. The decision marks a setback for the psychedelic space, as the agency has requested an additional Phase 3 study to further investigate the safety and effectiveness of MDMA. Lykos Therapeutics, the company behind the application, will need to conduct further research to address the FDA's concerns.
View original story
Similar markets
Approved without restrictions • 25%
Approved with restrictions • 25%
Rejected • 25%
Decision delayed • 25%
Effective for both PTSD and alcohol use disorder • 25%
Effective only for PTSD • 25%
Effective only for alcohol use disorder • 25%
Not effective for either condition • 25%
Approved without restrictions • 25%
Approved with restrictions • 25%
Not approved • 25%
Decision delayed • 25%
Significant positive results • 25%
Moderate positive results • 25%
No significant results • 25%
Negative results • 25%
Significant improvement • 25%
Moderate improvement • 25%
No significant change • 25%
Worsened condition • 25%
Yes • 50%
No • 50%