Optimi Health is set to initiate a Phase III clinical trial to assess methylenedioxymethamphetamine (MDMA)-assisted therapy to treat individuals living with post-traumatic stress disorder (PTSD) in Canada.
The Health Canada-authorised trial is planned to start next year and will enrol up to 100 participants at sites across the country.
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It will focus on veterans, as well as both existing and former frontline workers such as police, paramedics, firefighters, healthcare workers, and members of the military.
Participants will receive synthetic MDMA hydrochloride manufactured by Optimi Health during two supervised sessions, spaced several weeks apart, in combination with psychotherapy.
The company plans to administer the MDMA in two different dosage formats, with follow-up assessments conducted after the final session.
The primary efficacy outcome will be measured by a change in the clinician-administered PTSD scale (CAPS-5), which is commonly used to evaluate PTSD symptom severity.
Optimi Health CEO and co-founder Dane Stevens said: “On the heels of announcing our Phase II trial of natural psilocybin for the treatment of major depressive disorder, we are preparing to advance our synthetic MDMA into an approved Phase III trial in PTSD, with the goal of submitting both products for registration.
“PTSD and major depressive disorder are large, underserved markets. Millions of patients around the globe continue to struggle despite existing treatments, and veterans and frontline workers carry a disproportionate share of that burden. Psychedelic-assisted therapies have shown promise in helping patients find relief.”
PTSD can occur after experiencing or witnessing traumatic or life-threatening events, often resulting in severe and persistent emotional distress that disrupts daily life.
Optimi Health produces pharmaceutical-grade psychedelic substances, including MDMA and botanical psilocybin, at its British Columbia facilities.
While its MDMA products are prescribed in Australia within the country’s Authorised Prescriber Scheme, none have received market authorisation from Health Canada.
