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One of the biggest moments ever for psychedelic medicines has just occurred. And it might change the future of psychedelic drug development permanently.
What’s happening:
- MAPS Public Benefit Corporation has just filed a New Drug Application with the FDA for MDMA assisted therapy
- This is the first New Drug Application to ever be submitted to the FDA for a psychedelic medicine
Why it matters:
- PTSD is notoriously difficult to treat and lacks effective therapeutics that make a lasting difference for patients
Going deeper:
- MAPS recently announced positive data from their Phase III clinical trial for MDMA as a treatment for PTSD
- MAPS has now demonstrated positive data from two separate studies focused on MDMA assisted therapies
The intrigue:
- If the FDA approves the New Drug Application, the DEA would need to reschedule MDMA to make it available for medical use
By the numbers:
- The application is a culmination of 30 years of clinical research on the therapeutic potential of MDMA for PTSD
- The FDA has 60 days to decide whether they will accept the New Drug Application will be accepted for review
- The FDA gave MDMA a Breakthrough Therapy designation more than 6 years ago
