- Optimi Health plans to initiate a Health Canada-authorized Phase 3 clinical trial in 2027 evaluating synthetic MDMA-assisted therapy for people with PTSD, following its planned Phase 2 trial of psilocybin for major depressive disorder.
- The study is expected to enroll up to 100 participants across multiple Canadian sites, focusing on veterans and current or former frontline workers, including military, police, paramedics, firefighters and healthcare workers.
- Participants will receive synthetic MDMA HCl during two supervised sessions combined with psychotherapy, spaced several weeks apart. The primary endpoint will assess changes in PTSD severity using the clinician-administered CAPS-5 scale.
- Optimi aims to advance both programs toward registration, but MDMA-assisted therapy remains investigational in Canada. None of the company’s MDMA products have received Health Canada market authorization, and their safety and efficacy are still under study.
Takeaways:
Optimi Health’s plan to start a Health Canada‑authorized Phase 3 trial of synthetic MDMA‑assisted therapy for PTSD in 2027 positions the company to potentially become an early mover in a regulated psychedelic‑therapy market in Canada, focused on veterans and frontline workers who face high unmet need. By running a 100‑patient, CAPS‑5‑based study across multiple Canadian sites and pairing MDMA with structured psychotherapy, Optimi is building the local evidence and clinical model needed for future registration, while already commercializing its MDMA in Australia and supplying Canadian patients through special‑access pathways.
Source: Globenewswire
