After decades of legal scrutiny, psychedelics such as MDMA and psilocybin were granted a stamp by Health Canada for medical purposes. The Canadian legislation allows the use of psychedelics for medical purposes beyond palliative care. This is a significant breakthrough for health professionals and advocates calling it a major step forward in the treatment of serious or life-threatening conditions. This is a great news for patients who are interested in psychedelic treatment for mental illness. It will also offer Compass Pathways (NASDAQ CMPS), ATAI Life Sciences, NASDAQ:ATAI), Revive Therapeutics Ltd.(OTCQB:RVVTF), Mind Medicine/MindMed (NASDAQ :MNMD), (NEO:MMED), Numinus Wellness (TSX :NUMI), (OTCPK :NUMIF), which are currently conducting clinical trials on various psychedelics) a smoother path to approval.
Numinus Wellness, TSX:NUMI (OTC:NUMIF),helps people to heal by the development and delivery innovative mental health care. Access to safe and evidence-based psychedelic assisted therapies is part of this. The company’s business model is based on psychedelic production, clinical care, and research to treat symptoms such as anxiety, depression, trauma, pain, substance use, and other illnesses.
Numinus Wellness declared that it had completed all steps necessary to enroll participants in its MAPS Public Benefit Corporation Study, a multi-site extension study of MDMA assisted psychotherapy for PTSD (MAPPUSX), on January 18. Health Canada approved the study, as well as ethical approval from an Institutional Review Board. The Section 56 exemption was granted by the Controlled Drug and Substance Act. This allowed the use of MDMA for testing the safety and effectiveness in treating severe PTSD during the clinical trial.
MAPS is the most prominent developer of MDMA-assisted treatment training programs, protocols and research. Science Magazine named MAPS’ MDMA assisted therapy for PTSD as one of its top ten Scientific Breakthroughs in 2021. Numinus hosts the Canadian MAPPUSX sites in Quebec and British Columbia. These sites will be managed by Numinus’ two purpose-designed clinics. This will allow for quick completion of Canada’s MAPS trial.
Numinus Wellness recently was promoted to the TSX. It also announced that it had submitted the clinical trial application to Health Canada (CTA), for Phase 1 of its HOPE study on a natural derived Psilocybe extract formulation called NBIO-01. This milestone consolidates and advances the company’s long-standing efforts to develop safe and effective psychedelic drugs from its Health Canada-licensed research center, Numinus Bioscience.