Optimi launches Health Canada-authorized Phase 3 MDMA PTSD trial
Optimi Health announced plans to initiate a Health Canada-authorized Phase 3 clinical trial of its synthetic MDMA HCl for post-traumatic stress disorder, expected to begin in 2027. The multi-site Canadian study will enroll up to 100 participants, focused on veterans and current or former frontline workers, and will administer two supervised MDMA-assisted psychotherapy sessions given several weeks apart. The primary efficacy endpoint is change in the clinician-administered PTSD scale (CAPS-5). None of Optimi’s MDMA products currently have Health Canada market authorization, though the company supplies products to clinics in Australia since October 2024.
Optimi will run a Health Canada‑authorized Phase 3 MDMA PTSD trial.
Context
The company recently announced a Phase 2 psilocybin trial and supplies clinics in Australia since October 2024. It now plans a Health Canada-authorized Phase 3 MDMA trial starting in 2027. If the trial succeeds, the company intends to use…
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