MDMA Therapy For PTSD Faces FDA Delay: Are There Other Ways Forward?
The U.S. Food and Drug Administration (FDA) has issued a complete response letter for MDMA-assisted psychotherapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD) in which it calls for an additional phase 3 trial to further evaluate its safety and efficacy. As Psychiatric Times reported, this decision puts on hold what could have been a landmark approval for the treatment of PTSD with MDMA, also known as midomafetamine.
Despite the setback, Lykos Therapeutics, the company behind the MDMA-AT treatment, remains determined. Lykos has expressed confidence that the FDA’s concerns could be addressed using “existing data, post-approval requirements or through reference to the scientific literature.” Discussions between the company and the FDA are ongoing, as Lykos seeks a clear path forward.
Other Psychedelics In The Pipeline
While MDMA’s future remains in question, several other psychedelic treatments continue to progress through clinical trials. Atai Life Sciences (NASDAQ:ATAI) recently announced promising results from a phase 1b trial of VLS-01, a buccal film formulation of N,N-dimethyltryptamine (DMT), for treatment-resistant depression (TRD). The …