This is Why MAPS’ MDMA PTSD Clinical Trial was Denied
The FDA released its complete response letter rejecting Lykos Therapeutics’ MDMA application for PTSD treatment. The August 2024 letter reveals three critical flaws that doomed the groundbreaking psychedelic therapy trial.
| Key Takeaway | Impact |
|---|---|
| Failed to report “positive” adverse events | Compromised safety data reliability |
| No proof effects last beyond 18 weeks | Cannot establish durability for chronic condition |
| 40% of participants had prior MDMA use | Created selection bias and unblinding risk |
| High prescreening failure rates | Suggests non-representative study population |
| FDA requires new clinical trial | Delays approval by several years |
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Safety Data Concerns Sink Application
The FDA discovered that researchers systematically avoided reporting positive effects as adverse events. Study training materials explicitly instructed sites not to report favorable experiences like euphoria or mood changes. This violated FDA protocols for drugs with abuse potential.
The agency found that training materials described adverse events as “NOT positive or favorable effects,” while the actual protocol required reporting “any medical occurrence.” FDA inspections uncovered unreported adverse events at multiple sites, raising serious questions about data integrity.
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Treatment Benefits Failed Durability Test
PTSD is a chronic condition requiring lasting treatment effects. The MDMA trials only followed patients for 18 weeks after their final dose. The follow-up study designed to test durability contained major flaws that rendered it useless.
The MPLONG study included just a single visit per participant, with timing ranging from 6 months to 2 years. Many patients received other treatments between studies. Only some participants enrolled, creating potential bias through self-selection.
Selection Bias Undermined Results
Approximately 40% of study participants had previously used MDMA recreationally. This rate far exceeds the general PTSD population, where lifetime MDMA use ranges from 16% to 21% according to national surveys. The FDA also discovered extremely high prescreening failure rates.
These factors suggest researchers may have cherry-picked participants who were more likely to respond positively. Prior MDMA users could more easily identify the active drug, breaking the study blind and creating expectation bias.
The FDA now requires a completely new clinical trial addressing all three concerns before reconsidering approval.
