News|Videos|August 8, 2024

As FDA Decision on MDMA for PTSD Looms, What Would Approval Mean for Mental Health Treatment?

Name: What Would MDMA Approval Mean for Future of Mental Health Treatment?
Uploaded: 2024-08-08T20:59:08.743Z
Duration: 11 min 30 s
Description: Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses the implications of a potential FDA approval of MDMA-assisted therapy for PTSD.

Author(s)Killian Meara

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses the implications of a potential FDA approval of MDMA-assisted therapy for PTSD.

The FDA’s decision on a new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) is quickly approaching, with a Prescription Drug User Fee Act (PDUFA) date set for August 11. The agency’s verdict has been highly anticipated and could mark a historic shift in psychedelic medicine, as it would be the first psychedelic-assisted therapy approved in the United States.