FDA AdCom to review Lykos’ MDMA-assisted therapy for PTSD

The US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will review data supporting the new drug application (NDA) submitted by Lykos Therapeutics for midomafetamine (MDMA) capsules used in combination with psychological intervention (MDMA-assisted therapy") for adults with post-traumatic stress disorder (PTSD).

Lykos (formerly MAPS Public Benefit) noted that this will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years. As with all advisory committee meetings, there will be an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing.

Nascent psychedelic-based treatment market