Lykos Therapeutics Completes European Phase 2 Study of MDMA-Assisted Therapy for PTSD

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced the successful completion of their Phase 2 study (MP18) in Europe. This open-label study examined the feasibility and safety of using MDMA capsules, combined with psychotherapy, to treat adults with PTSD (post-traumatic stress disorder).

Building on US Progress

This European study follows the completion of Lykos’ pivotal Phase 3 trials in the United States. Their New Drug Application (NDA) for MDMA-assisted therapy is currently under review by the FDA (U.S. Food and Drug Administration).

Addressing a Global Need

“There’s a significant unmet need for novel treatment options for mental health conditions in Europe,” said Lykos CEO Amy Emerson. By seeking FDA approval first, they believe the learnings will be valuable for their European regulatory strategy. They are exploring ways to bring MDMA-assisted therapy to patients outside the US.

The European Study

The study involved 21 participants across sites in five European countries. It also included an optional sub-study using fMRI to assess brain activity changes in PTSD patients.

Importance of the Study

“This Phase 2 study is crucial for building evidence on the safety and effectiveness of MDMA-assisted therapy,” stated Dr. Eric Vermetten, lead investigator and professor of psychiatry at Leiden University Medical Center. PTSD is a significant issue in Europe, with a reported prevalence of up to 6.7%, highlighting the urgent need for new treatments.

Lykos Seeks FDA Approval by August 2024

On February 9, 2024, the FDA received Lykos’ NDA for MDMA capsules combined with psychological therapy for PTSD. The FDA granted Priority Review with a target action date of August 11, 2024. If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy ever.

Important Safety Information

MDMA capsules have not been approved by any regulatory agency. The safety and effectiveness of MDMA for treating PTSD are still under investigation. Lykos Therapeutics is also studying MDMA for other potential uses.

About Lykos Therapeutics

Lykos Therapeutics, a public benefit corporation founded by MAPS, aims to transform mental healthcare. They leverage their extensive experience in evidence-based research to develop and test potential psychedelic therapies for mental health conditions, with an initial focus on PTSD. Their mission extends beyond profit, emphasizing positive impact for individuals, communities, and society as a whole.

Posted April 2024.

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