• Mydecine plans to launch a program to provide products and services to healthcare professionals, clinics, and hospitals in Canada looking to treat patients through psychedelic-assisted psychotherapy
• The products and services, which will be available for purchase as a package, include cGMP psilocybin and MDMA, therapy manuals, investigative brochures, protocol training, advisory services, and post-therapy support
• The planned launch follows an amendment to federal regulations allowing physicians to request and prescribe restricted drugs for treatment-resistant patients

Canada began the year on a high note by updating the Special Access Program (“SAP”), a move that demonstrates the government’s serious consideration of the potential of restricted substances to treat a range of conditions. The update removes a previous prohibition enacted in 2013 that outlawed the access of restricted drugs through the SAP.

Starting this month, healthcare professionals can request patient access to restricted drugs, listed in Schedules I – V of the Controlled Drugs and Substances Act (“CDSA”), for treatment of life-threatening or serious conditions when other therapies have proven unsuccessful, are unavailable in Canada, or unsuitable. MDMA (more commonly known as ecstasy) and psilocybin are among the drugs patients can access through the updated SAP (https://ibn.fm/aFu31).

As a direct response to the change, Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF), a biotechnology and digital technology company looking to transform the treatment of mental health and addiction disorders, on January 13 announced plans to launch The Special Access Support and Supply Program (“SASSP”). The program is intended to fill a critical void created by the update by providing products and services to thousands of physicians, clinics, and hospitals looking to treat patients through psychedelic-assisted psychotherapy (https://ibn.fm/O7CFD).

In addition, the SASSP will offer A-Z support to medical practices across Canada, re-enforcing the safety and effective integration of psychedelic-based treatments. As part of the program, healthcare professionals can purchase a package that includes cGMP psilocybin and MDMA, therapy manuals, investigative brochures, protocol training, advisory services, and post-therapy support for patients through Mindleap Health, Mydecine’s wholly-owned subsidiary.

Mydecine is currently producing cGMP certified pharmaceutical grade psilocybin and MDMA with coverage under a Health Canada Schedule 1 Drugs and Substances Dealer’s License in Alberta. Through the SASSP, the company believes it can help treat a significant patient population who need alternative treatment options for mental illnesses, particularly in cases where they have not responded to available evidence-based treatments. 

Notably, treatment resistance affects 20-60% of patients with mental illnesses/disorders (https://ibn.fm/QCeFp). With the Mental Health Commission of Canada noting that one in five people live with mental illnesses every year (about 7.6 million people today, based on the country’s population), treatment resistance indeed afflicts a significant population (https://ibn.fm/9ZNUN).

“By launching this program, we are providing the resources the thousands of non-psychedelic clinics and hospitals will need in order to safely and effectively integrate these therapies into existing medical practices,” stated Mydecine CEO Josh Bartch.

A 2016 study published in the Journal of Psychopharmacology and considered one of the first in the current psychedelic renaissance era established that a single dose of psilocybin lowered the rate of depression by 78% and anxiety by 83% six months after subjects had received treatment (https://ibn.fm/jJn12). Since then, numerous other studies have been conducted. A 2020 Johns Hopkins University study, for instance, showed that psilocybin with supportive psychotherapy relieves major depression, with half of study participants achieving remission through the four-week follow-up (https://ibn.fm/TnktS).

Psilocybin has also been evaluated as a potential treatment for Post-Traumatic Stress Disorder (“PTSD”). A 2020 study found that “participants seemed to improve over time with respect to their symptoms of both PTSD and complicated grief” (https://ibn.fm/THVQv). Mydecine is also planning a Phase 2A clinical trial focusing on PTSD in front-line and emergency medical service (“EMS”) workers and veterans. This study will use the company’s lead drug candidate, MYCO-001, which is made up of 99% pure psilocybin.

Relatedly, a 2021 study demonstrated that “MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities,” concluding that MDMA-assisted therapy “represents a potential breakthrough treatment.”

For more information, visit the company’s website at www.Mydecine.com.

NOTE TO INVESTORS: The latest news and updates relating to MYCOF are available in the company’s newsroom at https://ibn.fm/MYCOF

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