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FDA Grants Priority Review For MDMA

February 15, 2024
x min read

MDMA assisted therapy is now on step closer to finding its way into clinics in the United States.

What’s happening:

  • The United States FDA has granted MDMA assisted therapy a priority review to Lykos Therapeutics
  • The priority review means the FDA has accepted the new drug application from Lykos Therapeutics and will provide an answer on an official approval within six months

Why it matters:

  • Lykos Therapeutics is founded on more than two decades of clinical research done by the Multidisciplinary Association for Psychedelic Studies and is now in the position to be the first company to ever have a psychedelic assisted therapy become approved by the FDA to be administered in a clinical setting

Going deeper:

  • Lykos Therapeutics was formerly known as MAPS Public Benefit Corporation and recently raised $100M in venture capital to become a for profit biotechnology company
  • The new drug application that was accepted for priority review by the FDA is focused exclusively on MDMA assisted therapy for individuals with PTSD

The fine print:

  • The priority review from the FDA does not mean that MDMA assisted psychotherapy will be approved, but rather that the FDA is committing to give a final regulatory decision at some point within the next six months

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