Numinus Wellness Inc (CVE:NUMI) (OTCMKTS:LKYSF) (FRA:LR23) announced it had received Health Canada approval for the MAPS-sponsored open label study of MDMA-assisted therapy for post-traumatic stress disorder (PTSD).
MAPS, or the Multidisciplinary Association for Psychedelic Studies, promoted research into MDMA-assisted therapy in the form of training programs and treatment protocols.
Approval at the federal level means that Vancouver-based Numinus can now transition the study into the final stages of training staff, sourcing medication and recruit patients.
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Numinus and MAPS Public Benefit Corporation (MAPS PBC) will collect safety and efficacy data on MDMA-assisted therapy in the hopes of making it available for people suffering from PTSD in Canada.
"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 Payton Nyquvest, CEO of Numinus, in a statement.
"At Numinus, we are focused on expanding patient access to psychedelic-assisted therapies such as MDMA for PTSD, and we are gratified that our study will provide safety and outcome data to regulators to support integration of this treatment into mainstream mental health care."
Early data looks promising
Amy Emerson, CEO of MAPS PBC, added that it is “critical” to gain data on outcomes from a diverse group of clinical environments as research into MDMA-assisted therapy gains traction.
"Clinical studies conducted for the purpose of regulatory approval often address research questions focusing on safety and efficacy of the treatment. This collaborative demonstration study with Numinus will build upon MAPS-sponsored multi-site studies, which enrolled some Canadian participants and will provide new and comprehensive information about the effectiveness of MDMA-assisted therapy for populations with PTSD and concurrent disorders."
Earlier this year, in May, MAPS announced results from its Phase 3 randomized clinical trial confirming the efficacy and safety of MDMA-assisted therapy for PTSD under the MAPS protocol. The trial demonstrated that 88% of participants who received three controlled and supervised MDMA-assisted therapy sessions experienced a “clinically significant” reduction in symptoms, with 67% no longer qualifying for PTSD diagnosis in comparison to 32% of participants randomized to placebo, according to a statement from Numinus.
Numinus medical and therapeutic services director Dr Devon Christie will take the reins as the study’s qualified investigator.
"Health Canada should be recognized for its ongoing leadership through its support of this study," Christie said. "At our Vancouver clinic, we have spent months establishing the physical, technical, clinical and human resource infrastructure needed to move the study forward and ultimately foster greater access to MDMA-assisted therapy."
Contact Angela at angela@proactivienvestors.com
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