As of April 12, 2021 Institutional Review Board (IRB) approval was obtained for multiple study sites for our open-label study to assess the safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for treatment of posttraumatic stress disorder (PTSD) in up to 100 participants who received therapy with inactive placebo in our parent Phase 3 studies). Sites that have received IRB approval include Charleston, South Carolina, Boulder, Colorado, Fort Collins, Colorado, Los Angeles, California, San Francisco, California (private practice), New York, New York (private practice, and Boston, Massachusetts. The study has been reviewed by the US FDA and Health Canada and cleared as safe to proceed.
