Psychedelics are going mainstream. Not only is the US FDA supportive of research, dozens of medical studies are proving such treatments could be helpful, including Johns Hopkins Medicine and New York University. In research to date, psilocybin has been found to help treat mental health issues, such as depression, anxiety, obsessive-compulsive disorder, and PTSD. LSD may be able to help patients with alcohol addiction and other mental disorders. MDMA-assisted therapy could help treat eating disorders, including anorexia and binge eating.
In addition, according to Kevin Matthews, founder of The Society for Psychedelic Outreach, Reform, and Education (SPORE), as quoted by Rolling Stone, “My hope with the Biden administration and other lawmakers is that they’re going to be receptive to having a conversation about psilocybin and other psychedelics,” says Matthews. “We’re facing a global mental health and addiction crisis, and that’s only been accentuated by COVID-19 with the lockdowns and business closures and further isolation. We need radical, safe effective solutions to address this emergency before it gets any worse.”
That’s substantial news for companies such as Cybin Inc. (NEO:CYBN)(OTC:CLXPF), Mind Medicine Inc. (OTC:MMEDF), Compass Pathways (NASDAQ:CMPS), and Mind Cure Health Inc. (CSE:MCUR)(OTC:MCURF).
Also, take a look at Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF)
Numinus Wellness Inc. just announced that the single-arm, open-label, compassionate access1 trial for MDMA-assisted therapy has made significant progress towards treating patients with posttraumatic stress disorder (PTSD). This trial is being pursued in collaboration with MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), the leading developer of the treatment protocols, research and MDMA-assisted therapy training programs.
“We are excited to share an update on the progress of our MDMA compassionate access trial with the full recognition that existing therapies for PTSD are inadequate,” said Payton Nyquvest, CEO of Numinus. “At Numinus, we are pleased to help foster a promising regulatory landscape that will contribute to a better understanding that psychedelic-assisted psychotherapies are a viable, safe, and necessary avenue for expanding existing treatment options. We look forward to continued collaboration with MAPS PBC and will work together to provide those experiencing PTSD with more treatment options.”
This first-of-its-kind trial in Canada has advanced and successfully transitioned into the pre-implementation stage at Numinus’ Vancouver clinic. This follows the successful completion of several milestones, starting with the recruitment of therapists, physicians, and staff in preparation for participant enrolment and the ultimate analysis of therapy outcomes. The highly qualified cohort of medical staff will be responsible for collecting safety data for Health Canada to further implement key research that supports individuals living with PTSD who have not benefited from existing treatment options.
In November 2020, eight Numinus therapists graduated from Part B of the MAPS MDMA therapist training program. Through their roles within the trial, they will complete the supervision requirement for certification as fully qualified MDMA therapists.
A draft MDMA-assisted therapy protocol for PTSD has been adapted for the trial, including clear guidance surrounding necessary screening processes, patient health histories, and indications and potential contraindications before accepting participants. Initial regulatory meetings with Health Canada to define the trial’s implementation science strategy have been completed, and the next steps will include obtaining ethical and Health Canada approvals to allow the recruitment of participants according to COVID-19 public health protocols.
“Developing a skilled workforce is a key challenge for the safe delivery of psychedelic-assisted therapies, so we are pleased to engage with Numinus to train therapists in the MDMA-assisted therapy protocol for PTSD,” said Amy Emerson, CEO of MAPS PBC.
Numinus is also pleased to announce that its Medical and Therapeutic Services Director, Dr. Devon Christie, will serve as both the trial’s Principal Investigator, and as a therapist. Dr. Christie is a family physician with a focus in multidisciplinary pain management, is a certified Relational Somatic Therapist, and is already MAPS-trained in the delivery of the MAPS MDMA-assisted therapy for PTSD.
“I am thrilled to be involved in a long-awaited clinical program that will help pave the way towards wider use of MDMA-assisted psychotherapy for those experiencing PTSD,” said Dr. Christie. “The key milestones announced today are a true testament to our teams’ commitment to establishing the physical, technical, clinical and human resource infrastructure needed to swiftly move through the trial’s formal implementation stages and ultimately towards the recruitment of the first participant.”
The safety and efficacy of MDMA-assisted psychotherapy is currently under investigation
It has not yet been approved by Health Canada or the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.
Health Canada recommends compassionate access open-label clinical trials when drug manufacturers anticipate exceptional demand for a drug, “to meet the needs of patients not eligible for enrollment in other pivotal trials” (Special Access Program for Drugs: Guidance document for industry and practitioners, Published 2020-10-14). This program is not related to the U.S. FDA Expanded Access program, sometimes referred to as “compassionate use” or the Breakthrough Therapy designation.
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