A Vancouver-based company has received approval from Health Canada to study MDMA-assisted therapy for post-traumatic stress disorder (PTSD).
“We are thrilled that Health Canada has issued its No Objection Letter allowing this important study to proceed and, in doing so, potentially advance Canada toward a legal, regulated system for MDMA-assisted therapy,” said CEO Payton Nyquvest.
Numinus’ study will look at the safety and feasibility of using MDMA-assisted therapies to treat PTSD.
Researchers will collect data on the safety and effectiveness of the treatment in the hopes of making MDMA-assisted therapy available to all Canadians living with PTSD.
In particular, the company hopes to create access for patients who have no other treatment options.
With federal approval granted, researchers can begin recruiting participants, importing medication, and training staff.
The study is being done in collaboration with MAPS Public Benefit Corporation (MAPS PBC), a subsidiary of the Multidisciplinary Association for Psychedelic Studies.
In May, MAPS released results from a Phase 3 clinical trial which confirmed the “substantial efficacy and safety” of MDMA-assisted therapy for PTSD.
Of the 90 participants, 88% had a “clinically significant” reduction in their PTSD symptoms, and 67% no longer qualified for a PTSD diagnosis.
“As research into MDMA-assisted therapy grows, it is critical that we develop data on outcomes from a diverse, real-world array of clinical environments,” said Amy Emerson, CEO of MAPS PBC.
“[This study] will provide new and comprehensive information about the effectiveness of MDMA-assisted therapy for populations with PTSD and concurrent disorders.”