Armed Forces veteran approved for psilocybin therapy through Health Canada special access program

06 Oct 2023 --- A Canadian armed forces veteran suffering from treatment-resistant depression (TRD) has been approved for macro-dose psilocybin treatment and assisted psychotherapy starting this month. The approval of the psychedelic was granted under the Health Canada Special Access Program (SAP) and is consistent with the Summit-90 clinical trial protocol.

“In January 2022, regulatory changes came into effect that made it possible for health care practitioners to request access, on behalf of their patients, to restricted drugs like psilocybin and MDMA through the SAP,” Charlaine Sleiman, spokesperson, Health Canada and the Public Health Agency of Canada, tells Nutrition Insight.

“The SAP is not intended to be a mechanism to promote or encourage the early use of drugs or to circumvent the clinical trials review and approval process or the new drug approval process, but rather to provide compassionate access to drugs on a patient-by-patient basis.”

The patient will take Apex-90 psilocybin with assisted psychotherapy following Apex’s Investigator Brochure (IB) and Therapy Manual (TM) under the 160 patient phase 2b Summit-90 trial, which recently completed patient pre-screening. The trial evaluates severe depression and standalone PTSD symptoms, chronic pain and anxiety.

Medical rationale used
Most psychedelics are “controlled substances” in Canada and fall under the Controlled Drugs and Substances Act. It is subject to the FDA and its regulations, which require that all new drugs be reviewed for safety, efficacy and quality before being authorized for sale.

“It is illegal to possess, produce or sell psychedelic drugs without appropriate authorizations from Health Canada,” Sleiman explains.

SAP gives healthcare practitioners access to non-marketed or unauthorized drugs for patients with severe or life-threatening conditions when conventional treatments have failed, are unsuitable or unavailable.Health Canada only grants access to specific drug treatments when all conventional therapies have failed.

“The SAP provides compassionate access to drugs on a patient-by-patient basis, and access is not guaranteed. A practitioner initiates a request on behalf of a patient and ensures that the decision to prescribe the drug is supported by credible evidence available in the medical literature or provided by the manufacturer,” Sleiman underscores.

“It is also the practitioner’s responsibility to ensure that patients are well informed of the possible risks and benefits of the drug being requested.”

On a case-by-case basis
The healthcare practitioner has to submit a request to Health Canada detailing the medical rationale for using the drug. If it is approved, they can get the drug directly from the manufacturer or another authorized supplier.

The veteran, who has not been named, says: “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.”

“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.”

Apex successfully supported Canada’s first psilocybin SAP approval with its IB to treat six patients experiencing end-of-life distress in 2022. Apex will support additional SAP applications for physicians interested in accessing psilocybin for their veteran patients beginning in 2024.

“Decisions to authorize or deny requests are made on a case-by-case basis, taking into consideration the nature of the medical emergency, the availability of marketed alternatives and the information provided in support of the request regarding the drug’s use, safety and efficacy,” says Sleiman.

“If Health Canada grants authorization, the practitioner agrees to report on the use of the drug, including any observed adverse drug reactions and, when requested, must account for all quantities received.”Psilocybin treatment was granted to a veteran under special circumstances following a rigorous review process.

Meanwhile, a retrospective cohort study of US veterans found that higher doses of vitamin D supplementation reduced suicide attempts and intentional self-harm by up to 48%. Published in Plos One, the research identified the decreased risk as most significant in black veterans with low blood serum levels.

After conventional therapies fail
Before being given market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the FDA. Health Canada reviews the evidence and if the department concludes that the benefits outweigh the risks and can be mitigated, the drug is given marketing authorization.

“Health Canada cannot authorize a therapeutic product unless a submission has been made to the department for evaluation, and no submission of a product containing psilocybin has been received by the department, explains Sleiman.

“In the case of psilocybin, this would mean that a manufacturer would need to submit a submission to Health Canada to request market authorization in Canada for their drug.

“This submission would have to include scientific evidence that demonstrates that psilocybin is safe, effective and of good quality for the treatment of the proposed indication (i.e., the treatment of the medical condition that the manufacturer intends to market the drug for),” Sleiman notes.

There are currently no drug submissions for psychedelic drugs undergoing the rigorous, science-based review process. “Health Canada continues to advocate that clinical trials remain the best method to advance the knowledge about products with a possible therapeutic benefit,” Sleiman says.

By Inga de Jong

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