Vancouver-based psychedelic biopharmaceutical company Apex Labs Ltd. received approval from Health Canada to conduct the study first at-home clinical trial in North America assess the safety and efficacy of several low doses of a self-administered oral synthetic psilocybin compound APEX-52 for the treatment of depression in veterans with PTSD.
Apex Labs is configured to optimize the standard of mental health care specifically for the veteran population bringing clinically supported psilocybin medications to market for depression in PTSD. In addition to developing the products, the company intends to evaluate their safety and effectiveness in a real-world environment by simultaneously working with veterans and their primary healthcare professionals to develop effective channels for patients to access these treatments.
In view of the No Objection Letter (NOL) filed by the Canadian federal agency on October 24 in response to Apex’s request, the Company CEO, Tyler Powell said that this endorsement “signals a will of Health Canada to enable Apex to move forward with a clinical pipeline focused on veteran patients with PTSD and a comorbid diagnosis of depression.
The CEO of Apex further explained, “Veterans are already treating themselves with micro-doses of unregulated psilocybin products without knowing the potency and safety of the product they are consuming. Our goal is to expand access to pharmaceutical-grade pharmaceutical products through regulated systems, providing transparency and support for patients in need. »
The a two-month trial will include a psychiatric examination. Nonetheless, its significance lies in the fact that this is the first clinical study to allow participants to consume a Good Manufacturing Practices (GMP) psilocybin drug at home, which may help reduce the stigma associated with taking psychedelics.
Arron Victory, Director of Corporate Strategy, believes Apex’s particular focus on the veteran community led to Health Canada’s approval. “It’s a nuanced approach to treating veterans with PTSD, and the current standard of care – talk therapy combined with antidepressants – has been an acknowledged failure in the veteran community,” he said. declared.
According to Victory, currently approved treatment does not work for veterans with PTSD due to emotional harm. “That’s when something you witnessed is so traumatic that it fundamentally erodes your current belief system,” Victory explained. “PTSD is an epidemic in the veteran community, and when you have a treatment-resistant chronic condition, you try anything once.”
Furthermore, he added, the growing interest in using psilocybin as a treatment for depression is because, unlike other drugs, it does not appear to have addictive properties.
Canada appears to be moving slowly towards regulated approval for the advancement of psychedelics as drugs. Recently, a The University of Ontario has received a reseller license from Health Canada allowing the psilocybin mushroom cultivation for further research.
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