Canada's first clinical trial of home psilocybin prescriptions

A pharmaceutical company called Apex Labs announced on November 1 that it would conduct the first North American clinical trial of multidose psilocybin prescribed at home. Apex Labs is a patient-focused pharmaceutical company specializing in psilocybin treatments for military veterans.

According to a press release, the trial known as APEX-002-A01-02 will explore the efficacy of APEX-52 (psilocybin) for veterans suffering from depression and post-traumatic stress disorder. Apex Labs received a «letter of no objection» from Health Canada on October 24.

Veteran patients will receive psilocybin for oral use.

Tyler Powell, CEO of Apex Labs, said he was delighted to introduce the drug to participating patients, allowing them to safely explore whether psilocybin could help them treat their health problems.

«This approval demonstrates Health Canada's willingness to allow APEX to move forward with a clinical pipeline focused on veteran patients with PTSD and a comorbid diagnosis of depression,« said Powell.

«Veterans are already self-medicating with microdoses of unregulated psilocybin products, unaware of the potency and safety of the product they are consuming. Our goal is to expand access to pharmaceutical-grade products through regulated systems, offering transparency and support to patients who need it.»

In January 2022, Health Canada amended its Controlled Drugs and Substances Act through its Special Access Program, to include psilocybin and MDMA.

«Emerging scientific evidence supports the potential therapeutic uses of certain restricted drugs, including restricted psychedelic drugs such as MDMA and psilocybin, which have received «breakthrough therapy» designation from the U.S. Food and Drug Administration for the treatment of post-traumatic stress disorder and treatment-resistant depression, respectively,» writes Health Canada.

Recently, the University of Guelph in Ontario, Canada, was authorized to conduct a study on psilocybin mushrooms. The university received a «distributor's license» from Health Canada on October 25, making it one of the first universities in the country to receive such approval.

Some Canadian patients at the end of life also received exceptional, individual authorization consuming hallucinogenic mushrooms.