A pharmaceutical company called Apex Labs announced on November 1 that it would conduct the first North American clinical trial of home-prescribed multidose psilocybin. 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 effectiveness of APEX-52 (psilocybin) for veterans with depression and post-traumatic stress disorder. Apex Labs received a “letter of no objection” from Health Canada on October 24.
Veteran patients will be given low-dose and multiple-dose psilocybin for oral use.
Tyler Powell, CEO of Apex Labs, said he was excited to introduce this drug to participating patients, allowing them to safely explore whether psilocybin can help them with their health issues.
“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, providing 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 like MDMA and psilocybin that 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, Ontario (Canada), was granted permission 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 have also received exceptional and individual authorization to consume hallucinogenic mushrooms.