MAPS / LYKOS Pat themselves on the back..”Announcement: MAPS Congratulates Lykos Therapeutics on Acceptance of New Drug Application for MDMA-Assisted Therapy for PTSD “
Is it just me who thinks this is just pain self – congratulatory promotion?
February 9, 2024
The FDA has accepted a New Drug Application filed by Lykos Therapeutics for MDMA-assisted therapy for PTSD
The application was supported by clinical trial data collected over nearly two decades of research incubated by MAPS
The FDA granted the application Priority Review and is expected to announce its determination in August 2024
The Multidisciplinary Association for Psychedelic Studies (MAPS) congratulates Lykos Therapeutics, formerly MAPS Public Benefit Corporation, on its announcement that the U.S. Food and Drug Administration (FDA) has accepted its new drug application (NDA) for midomafetamine capsules used in combination with psychological intervention for individuals with PTSD. The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024 to make the review determination.
“Thirty-eight years ago, one of my primary motivations for founding MAPS was to carve a path for psychedelic-assisted therapies to become FDA-approved treatments. Today, with the notification that the FDA will evaluate MDMA-assisted therapy for PTSD for potential approval as early as August 2024, and backed by decades of research incubated by MAPS, we are celebrating the therapists and subjects who participated in the Phase 2 and Phase 3 studies and the team at Lykos Therapeutics on the historic accomplishment they have achieved. We hope that potential FDA approval of MDMA-assisted therapy for PTSD is only the first of many psychedelic-assisted therapies that become available by prescription.” –Rick Doblin, Ph.D., Founder and President, MAPS