A week after an FDA committee declined to support an midomafetamine (MDMA) treatment for post-traumatic stress disorder (PTSD), Lykos Therapeutics is looking to dispel some concerns about the therapy as the discussion has taken on a life of its own beyond the biotech world.
Long dismissed by top scientists and drug regulators, the use of psychedelics to treat mental health conditions has finally gained momentum over the last several years. But some proponents believe that progress was undercut this week, when one of the field’s most advanced therapies hit a significant setback.
US FDA panel votes against first MDMA-based PTSD treatment
As Lykos Therapeutics’ midomafetamine (MDMA) sits on the cusp of becoming the first FDA-approved psychedelic, the agency’s staff scientists have flagged a series of shortcomings that may have narrowed MDMA’s chances of winning that title.
The Institute for Clinical and Economic Review said it cannot fairly judge Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder because of concerns about certain elements of its clinical trials.
Lykos Therapeutics’ MDMA-assisted therapy is charting yet another first in the psychedelic field: an FDA advisory meeting.
US FDA panel to discuss first psychedelic-assisted PTSD treatment next month
MAPS Public Benefit Corporation, a California biotech attempting to bring MDMA-assisted therapy to market for mental health conditions, said it has raised more than $100 million in Series A funding a month after submitting its drug for FDA approval.