Optimi Health Plans Phase 3 MDMA-PTSD Trial for 2027

Optimi Health (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) has announced plans to initiate a Health Canada-authorized Phase 3 clinical trial in 2027 to evaluate MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The trial aims to enroll up to 100 participants across multiple Canadian sites, with a focus on veterans and current or former frontline workers, including military personnel, police, paramedics, firefighters, and healthcare workers. Participants will receive Optimi's synthetic MDMA HCl during two supervised sessions that combine MDMA with psychotherapy. The primary efficacy endpoint will measure changes in PTSD severity using the Clinician-Administered PTSD Scale.

This planned Phase 3 trial follows Optimi's recently announced Phase 2 trial of natural psilocybin for major depressive disorder and is part of the company's broader strategy to pursue registration for both products. Optimi noted that the safety and efficacy of MDMA-assisted therapy for PTSD remain under investigation, and none of its MDMA drug products have received market authorization from Health Canada. However, the company said clinics in Australia have been prescribing MDMA manufactured by Optimi since October 2024. To view the full press release, visit https://ibn.fm/tr50L.

Optimi Health Corp. is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. The company supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country's Authorized Prescriber Scheme and accessible in Canada through the Special Access Program. For more information, please visit https://www.optimi.net/.

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