The multicenter feasibility study involved 21 participants treated in the Netherlands, United Kingdom, Czech Republic, Germany and Norway.
Lykos Therapeutics said it has completed a European Phase 2 study of investigational MDMA-assisted therapy for treatment of adults with post-traumatic stress disorder.
The open-label, multicenter feasibility study of MDMA capsules in conjunction with psychological intervention involved 21 participants treated in sites in the Netherlands, United Kingdom, Czech Republic, Germany and Norway, according to Lykos.
“Successful completion of this Phase 2 study in Europe is an important step to build on the body of evidence evaluating the efficacy and safety of MDMA-assisted therapy in the United States, where this novel therapeutic approach now is under FDA review,” said Eric Vermetten, professor of psychiatry at Leiden University Medical Center and lead investigator of the study. “There is an urgent need for new and effective evidence-based treatments for PTSD in Europe where the reported PTSD prevalence is up to 6.7%.”
This past December, Lykos – formerly known as MAPS Public Benefit Corp. – submitted a new-drug application to the U.S. Food and Drug Administration for MDMA-assisted therapy.
In February, the FDA granted the application “priority review.” When the FDA grants priority-review status, the agency has six months to conclude its review process.
If the FDA approves the Lykos application, it would be the first MDMA-assisted therapy and psychedelic-assisted therapy legally available in the United States.
“Given the substantial need for new treatment options for individuals with mental-health conditions in Europe, the completion of this Phase 2 study is an important step to helping address unmet needs outside the United States,” said Amy Emerson, chief executive officer at Lykos Therapeutics. “By pursuing FDA approval of MDMA-assisted therapy first, we believe the learnings will be beneficial as we determine our regulatory strategy in the United Kingdom and Europe. We are exploring different avenues to bring MDMA-assisted therapy to market outside the United States.”