Psychedelic-Assisted Therapy for PTSD: On the Verge of FDA Approval

Lykos Therapeutics (formerly MAPS PBC) announced that the U.S. FDA has accepted its new drug application for MDMA used in combination with psychological intervention, including psychotherapy for individuals with post-traumatic stress disorder (PTSD). The FDA has granted the application priority review, with a decision expected by mid-August 2024.

Innovation in mental health has stagnated for decades. In the past three years, Europe has approved only 1 new psychiatric treatment, compared to 68 in oncology. While the U.S. is on the brink of approving the first psychedelic-assisted therapy, Europe significantly lags behind. This is primarily because the current incentives and rewards for companies to conduct large-scale pivotal trials on psychedelics are insufficient in Europe, highlighting the need for enhanced support and incentives to advance novel mental health treatments.

Read PAREA's full news release here: bit.ly/3SWbyVx