A Vancouver-based pharmaceutical company will run the first take home psilocybin clinical trial in North America.
Health Canada has approved phase two of the trial by Apex Labs, which will evaluate the safety and efficacy of its low dose, multi-dose product APEX-52 in treating depression in veterans with post-traumatic stress disorder.
Veterans Affairs Canada estimates up to 10 per cent of war-zone veterans have been diagnosed with PTSD. That’s twice the amount of diagnoses the general adult population has received, according to Statistics Canada.
Apex Labs CEO Tyler Powell says many veterans are already self-medicating with micro-doses of unregulated psilocybin products
“Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need,” Tyler said in a statement released Tuesday.
The Oct. 24 approval comes nearly 11 months after Health Canada broadened the Special Access Program to include MDMA and psilocybin, a psychedelic compound found in “magic mushrooms” that research shows can have antidepressant effects.
This exemption means that health care professionals can use psilocybin on a case-to-case basis if they think a patient would benefit.
Apex Labs Chief Strategy Officer Arron Victory believes the company’s specific focus on the veteran community led to the historic approval from Health Canada.
“It’s a nuanced approach to treating veterans with PTSD, and the current standard of care has been an acknowledged failure in the veteran community,” says Victory, who served in Canada’s military for 14 years.
He says the current standard of care—a combination of talk therapy and anti-depressant medication—doesn’t work for veterans with PTSD due to moral injury.
“That’s when something you’ve witnessed is so traumatizing it basically erodes your current belief system,” Victory explains. “PTSD is an epidemic in the veteran community, and when you have a chronic condition that’s treatment resistant, you’ll try anything once.”
While the two-month trial will include psychiatric oversight, it’s the first of its kind to allow participants to consume a psilocybin drug product at home alone.
“Patients being able to take it in their home reduces the stigma of taking this drug and makes it more normalized,” says Victory.
He adds the growing interest in the use of psilocybin as a treatment for depression is partially due to the fact that, unlike other medications, there’s no evidence the drug is something people become reliant on.
Cost can be a barrier for people who take the unregulated path. As demand for psilocybin therapy grows in Canada, and worldwide, some therapists are charging between $2,500-5,000 or higher for a single session.
Source: First-of-its-kind psilocybin trial approved in Vancouver