Braxia Scientific has received approval from Health Canada to provide psilocybin-assisted psychotherapy for a patient with Major Depressive Disorder (MDD) in Ontario.

The psilocybin-assisted therapy will be delivered through Braxia’s wholly owned subsidiary Canadian Rapid Treatment Centre of Excellence (CRTCE).

The approval is Braxia‘s first psilocybin-assisted therapy treatment using Health Canada’s SAP, however, the company was the first to receive Health Canada approval for a multi-dose psilocybin-assisted therapy clinical trial in July 2021.

Chief Medical and Scientific Officer at Braxia Scientific, Dr Joshua Rosenblat, commented: “Being among the first to begin delivering psilocybin-assisted therapy treatments in Canada last year through our clinical trial, we have developed and optimised the infrastructure, including rigorous training for our therapists through our Braxia Institute, to provide a positive patient experience while optimising outcomes.”

“To our knowledge, this is the first Health Canada SAP approval for psilocybin-assisted therapy for a person with Major Depressive Disorder in Ontario. 

“My patient and I are extremely grateful for this opportunity to access this promising treatment. Health Canada was very responsive to this request, promptly providing the Letter of Authorization. 

“This rapid approval stands in contrast to the previously required Section 56 exemptions that could take years to fully process. Allowing use of the SAP will be incredibly beneficial for patients in need of this treatment that are unable to receive it through psychedelic clinical trials.”

Chairman and CEO of Braxia Scientific, Dr Roger McIntyre, commented: “Since opening our first clinic in 2018, in Toronto, Canada, our focus has been on creating a true centre of excellence for people living and suffering with depression to gain access to the most effective treatments. 

“Our ability to deliver psilocybin-assisted therapy is an important step in our journey to achieving our vision of finding a cure for depression.

“The experience of our therapists who have already delivered this novel treatment in multiple doses to multiple patients in our ongoing psilocybin trial, combined with data we’ve collected to date and expect to read out in the coming weeks, provides an excellent opportunity for new applicants to receive access to the most advanced clinical protocols and care to achieve best outcomes in this field. 

“In addition to providing access to innovative treatments for depression, Braxia Scientific is a   leader in comprehensive research, development and best-practices implementation of psilocybin, ketamine and related agents.”

Health Canada has granted approval to Numinus’ application to complete psychedelic-assisted therapy using psilocybin to treat an applicant with treatment-resistant depression.

In January this year, Health Canada amended its Special Access Program (SAP) to include access to psychedelic compounds on a case-by-case basis.

To be considered for the SAP program, an applicant must have a serious or life-threatening condition where conventional treatments have failed, are unsuitable or are not available in Canada.

Recent research has shown that psilocybin-assisted therapy holds promise as a treatment for a number of different mental health disorders such as depression. Numinus, which is focused on advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, put forward an application for its psilocybin therapy to be included on the (SAP).

Founder and CEO of Numinus, Payton Nyquvest, commented: “I am proud that Numinus is working with Health Canada to help Canadians with mental health challenges in ways that were not previously available, including using psilocybin-assisted therapy through Health Canada’s SAP.

”The SAP recognises a growing body of research that has consistently shown the efficacy of psychedelic-assisted psychotherapy to treat a broad range of mental health conditions that are extremely difficult to treat with conventional therapies. 

“We hope that our first psilocybin-assisted therapy treatment is the beginning for more opportunities for Canadian patients to obtain safe access to treatment and care in the mental health sector through psychedelic medicine.”

Numinus has confirmed that the treatment will take place at one of its Montreal clinics, consisting of psilocybin-assisted therapy including several preparatory and integration therapy sessions, medical consults and one psilocybin-dosing session. 

All practitioners involved in the treatment have been trained through Numinus’ proprietary psilocybin-assisted therapy protocol and Numinus will partner with Psygen Labs, an approved Health Canada supplier, to provide the synthetic psilocybin to be taken orally during the dosing session.

Dr. Andrew Bui-Nguyen, Numinus’ Québec regional medical director, who completed the application, said: “Numinus has been working with this applicant through other available services over an extended period and we are proud that we can now provide this deeply important treatment. 

“To our knowledge, this is the first Health Canada SAP approval for psilocybin-assisted therapy for someone suffering from treatment-resistant depression in Québec, and the first time our Numinus team will provide this treatment outside of the clinical trial setting.”

As they are approached by treatment-resistant patients who meet this criteria, Numinus-affiliate physicians plan to make additional applications for clients suffering from a range of mental health conditions in BC and Québec.

The non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) has confirmed it has now fully enroled its Phase III trial of MDMA-assisted therapy for PTSD.

It is currently estimated that more than 300 million people are living with PTSD worldwide, with around 12 million experiencing the condition each year in the US. 

About half of people with PTSD achieve symptom reduction through psychotherapy or pharmaceutical interventions. However, for some, PTSD is a chronic condition resulting in serious comorbidities including anxiety, insomnia, hypertension, depression and substance use disorder.

MDMA for PTSD

The MAPS Phase III trial is aiming to help meet the unmet need for treatment in this area, and is expected to take place at 13 sites across the US and Israel. The second, confirmatory Phase III trial of MDMA-assisted therapy for PTSD is now fully enrolled at 13 sites in the United States and Israel.

MAPS’ first Phase III trial indicated that MDMA may be a safe and effective treatment for PTSD resulting from any cause, with 88 per cent of participants demonstrating a clinically significant reduction in PTSD symptoms two months after the last experimental session, with no serious safety signals emerging. 

After negotiating a special protocol agreement with the US Food and Drug Administration (FDA) for the confirmatory trial, MAPP2 was designed to enrol at least 100 participants in order to confirm the efficacy and further investigate the safety of the treatment.

If the MAPP2 study results, available after October 2022, are statistically significant for a reduction in PTSD symptoms and meet the FDA standards for safety, MAPS and MAPS PBC are planning to submit a New Drug Application to the FDA in the first half of 2023.

CEO of MAPS Public Benefit Corporation, Amy Emerson, commented: “For nearly 20 years, MAPS has sponsored innovative, careful research into the potential of MDMA to treat PTSD. 

“MAPS PBC, supported through the dedication of staff, consultants, participants in the studies, and donors, has organised world-class research into a novel treatment for a devastating condition with too few treatment options. 

“Together, we are eagerly awaiting the possibility that our scientific inquiry may be confirmed in this critically important trial scheduled to be completed in October 2022.”

Associate director for Pivotal Programs, Charlotte Harrison, B.A., commented: ”The completion of enrolment brings us one step closer to making this novel treatment available to the many people who were not able to participate and accessible to those who need it most. 

“We are ever grateful for the participants who spent many hours on their healing journeys in this trial and to the therapists, study coordinators, doctors, and MAPS PBC staff who have dedicated their careers to this effort.”

BIPOC and LGBTQIA+

MAPS is implementing Health Equity initiatives to enrol BIPOC and LGBTQIA+ participants improved representation of populations most likely to develop PTSD following exposure to trauma.

MAPS highlights that, among Americans exposed to trauma, people of colour and LGBTQ+ individuals are more likely to develop PTSD, yet less likely to receive a diagnosis or have reasonable access to treatment. 

Research demonstrates that racial and ethnic alignment among healthcare providers and their patients can improve survival, safety and trust for patients. However, marginalised populations are historically underrepresented in clinical research, including in MAPS-sponsored trials. 

Through equity initiatives in therapist training and participant recruitment, participants in MAPP2 are more representative of the population of people living with PTSD.