MDMA-assisted therapy for PTSD to be reviewed by US FDA

American public benefit corporation (PBC) Lykos Therapeutics have announced that the US FDA Psychopharmacologic Drugs Advisory Committee (PDAC) will review data supporting their new drug application (NDA) for MDMA capsules, which are to be used in combination with psychological interventions for the treatment of PTSD in adults. 

Lykos Therapeutics, a California-based PBC, announced in a press release on May 6, 2024 that the US FDA will be investigating data in support of the company’s NDA for midomafetamine capsules, more commonly known as MDMA. Often used as a recreational drug, MDMA acts as a stimulant and a psychedelic. A synthetic chemical, MDMA affects how serotonin is used by neurons to communicate with each other. As a psychedelic, MDMA causes changes in perception and euphoric sensations for users. Investigational MDMA has been clinically studied for indications including PTSD but has never been approved by any regulatory agency.  

The US FDA PDAC will review the results of several studies evaluating the efficacy and safety of MDMA when used in combination of psychotherapy and other mental health support services. Amy Emerson, CEO of Lykos Therapeutics, states, “This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the [PDAC], a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy. We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD.” 

The FDA accepted the NDA for midomafetamine from Lykos Therapeutics in February 2024 for MDMA-assisted therapy of PTSD in adults. The NDA application was granted Priority Review. Drugs granted this review will, if approved, be classed with significant improvement in the safety or effectiveness of treatment, diagnosis, or prevention of serious conditions compared to standard applications. Should the midomafetamine capsules be approved, they will be the first drug product approved for MDMA-assisted therapy and psychedelic-assisted therapy. 

Source:  

Lykos Therapeutics Announces FDA Advisory Committee Meeting to Review Investigational MDMA-Assisted Therapy for PTSD [Accessed May 8, 2024] https://news.lykospbc.com/2024-05-06-Lykos-Therapeutics-Announces-FDA-Advisory-Committee-Meeting-to-Review-Investigational-MDMA-Assisted-Therapy-for-PTSD