We’ve reported on the Canadian federal government changing restrictions that prohibit the sale of illegal compounds, opening up the SAP (Special Access Program) to allow psychedelics, on a case-by-case basis, to be sold to approved doctors/therapists/pharmacists for patients in need.
Although still mired in red tape and the whims of bureaucratic decisions, it was an important legal step forward in getting more access for people in need.
Today we saw some fruits of these governmental decisions, as Numinus has been approved to provide psilocybin psychotherapy under the Special Access Program.
This will be Numinus’ first psilocybin-assisted therapy treatment outside of clinical trials, and will take place at one of Numinus’ Montreal clinics, consisting of psilocybin-assisted therapy including several preparatory and integration therapy sessions, medical consults and one psilocybin-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…”
There are many positives. Patients receiving much-needed help; regulatory agencies becoming more comfortable with the idea of psychedelic medicine; and companies like Numinus finally able to work with psilocybin in one of their clinics — a small realization of the future vision of the industry.
See below for the full press release and stay tuned for more.
NEWS PROVIDED BY
May 16, 2022, 07:30 ET
Approval Marks Numinus’ First use of Psilocybin-Assisted Therapy Treatment Outside of Clinical Trials
VANCOUVER, BC, May 16, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus”) (TSX: NUMI) (OTC: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced that Health Canada has approved Numinus’ application to complete psychedelic-assisted therapy using psilocybin to treat an applicant with treatment-resistant depression. This is Numinus’ first psilocybin-assisted therapy treatment outside of ongoing clinical trials, and among the first to use of this regulatory mechanism through Health Canada’s Special Access Program (“SAP”), which was amended January 5th, 2022 to include access to psychedelic compounds on a case-by-case basis.
Psilocybin-assisted therapy has shown a great deal of promise in treating depression, as demonstrated in recent clinical trials and studies.
“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,” says Payton Nyquvest, Founder and CEO, Numinus. “The SAP recognizes 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.”
The psychedelic-assisted therapy treatment will take place at one of Numinus’ 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.”
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. 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.
Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.