Canadian Military Veteran Receives Approval for Psilocybin Therapy

Despite being one of the world’s more liberal countries when it comes to drug reform (Canada has fully legalized cannabis for personal and commercial use) — the northern nation is lagging behind when it comes to psychedelic medicine reform.

While the US has a growing number of cities and states decriminalizing psychedelics (and even legalizing like in Oregon), Canadian municipalities have not kept up with the pace. Furthermore, Health Canada remains extremely stingy when it comes to granting people in need access to legal, therapeutic use of psychedelics.

Health Canada’s Special Access Program (SAP) is the only way patients can legally access psilocybin treatments outside of clinical trials. The SAP is only available for the treatment of patients with serious or life-threatening conditions when conventional therapies have failed — and each individual case must be approved by Health Canada, an extremely slow process that leaves hundreds of desperate patients unable to access therapies that could alleviate suffering or even save their lives.

The government is so slow in granting permission to patients that protests are being staged and TheraPsil is suing the Canadian government for infringing on people’s rights to heal themselves.

See Protests in Ottawa for Access to Psychedelic Medicine

With the bar set this low, we did receive some good news as Health Canada has granted permission for a Canadian military veteran to receive much-needed psilocybin therapy.

The Canadian Armed Forces veteran is suffering from Treatment Resistant Depression and has been authorized to receive Apex Labs’ APEX-90 macrodose psilocybin. The patient will be taking Apex’s psilocybin with assisted psychotherapy.

Baby steps and good news for this one patient. Yet too many Canadians in need are still left waiting despite having submitted legitimate claims supported by their doctors.

See the full press release below.

Canadian Veteran Receives Approval for APEX’s Psilocybin Therapy Through Health Canada’s Special Access Program

Veteran to receive APEX-90 macrodose psilocybin drug product in combination with assisted psychotherapy consistent with SUMMIT-90 clinical trial protocol.

VANCOUVER, BC, Sept. 27, 2023 /CNW/ – Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin treatments is excited to announce that a physician has been authorized to receive APEX-90 macrodose psilocybin drug product via Health Canada’s Special Access Program (SAP) for the treatment of a Canadian Armed Forces Veteran suffering from Treatment Resistant Depression (TRD). Dosing is expected October 2023. The patient will be taking APEX-90 macrodose psilocybin with assisted psychotherapy following APEX’s Investigator Brochure (IB) and Therapy Manual (TM) aligned with the protocol outlined in its Health Canada approved 160 patient phase 2b SUMMIT-90 statistically powered clinical trial, which recently completed patient pre-screening.

“Every Veteran matters but we are often left behind. I have been following existing standards of care for my depression and PTSD for a decade, and it just hasn’t been enough,” says the Canadian Armed Forces Veteran who received the approval. “The process to get an SAP was difficult but it is all we have to access these essential emerging treatments. I am grateful to the APEX team and my physician for moving this forward and hope more Veterans like me will gain access.”

Currently the primary mechanism through which Health Canada allows psilocybin access outside of clinical trials is the SAP. It allows health care professionals to access drugs of potential benefit that are not marketed or authorized for sale in Canada. The SAP is only available for treatment of patients with serious or life-threatening conditions when conventional therapies have failed.

“We are proud to have supported this SAP application from beginning to end and grateful for Health Canada’s guidance through the process,” says Arron Victory, APEX Co-Founder and Chief Strategy Officer. “This aligns with APEX’s vision to prioritize the Veteran Community as a key step towards broader access. We are committed to providing early access to Veterans alongside our traditional clinical program.”

APEX successfully supported Canada’s first psilocybin SAP approval with its IB to treat six patients experiencing end-of-life distress in April of 2022. The Company plans on supporting additional SAP applications for physicians who are interested in accessing APEX psilocybin for their Veteran patients beginning in 2024.

The SUMMIT-90 clinical trial is designed to investigate the safety and efficacy of APEX-90 for treatment of severe depression within diagnosed PTSD. Market authorization of APEX-90 has not been granted by Health Canada or other drug product regulators, and as a result APEX-90 is eligible for access in Canada through the SAP.

About SUMMIT-90

SUMMIT-90 is a statistically powered multi-centre randomized, double-blind, placebo-controlled phase 2b study of a macrodose psilocybin drug asset approved by way of a No Objection Letter (NOL) from Health Canada received on April 14th 2023. SUMMIT-90 evaluates multiple doses of APEX-90 macrodose psilocybin administered in-clinic with assisted psychotherapy for the treatment of severe depression in patients with diagnosed PTSD, recruiting 160 patients in Canada.

SUMMIT-90’s primary indication being studied is severe depression within diagnosed PTSD, and secondary indications include standalone PTSD symptoms, chronic pain, and anxiety.

About the Special Access Program (SAP)

In Canada, the SAP allows healthcare practitioners to access non-marketed or unauthorized drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or unavailable. To obtain access, the healthcare practitioner must submit a request to Health Canada detailing the medical rationale for the use of the drug, after which, if approved, the drug can be acquired directly from the manufacturer or another supplier authorized by Health Canada.

About Apex Labs Ltd.

APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care for patients with clinically proven psilocybin treatments. By bringing data supported, clinically evaluated drugs to market for depression and anxiety in PTSD, APEX’s strategy is focused on developing pharmaceutical products through phased clinical programs evaluating safety and efficacy across multiple indications, alongside a robust early access program.

The post Canadian Military Veteran Receives Approval for Psilocybin Therapy appeared first on Microdose.

Read More