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