As a first ever in North America, Vancouver-based pharmaceutical company Apex Labs will be conducting a take home psilocybin clinical trial to treat depression in veterans with post-traumatic stress disorder (PTSD)..Psilocybin is a psychoactive compound found in certain species of fungi which — much to the distaste of mycologists and those studying the compound — is often referred to as “magic mushrooms” or “shrooms.”.Apex says it's bringing data supported, clinically-evaluated psilocybin treatments to market for depression in veterans with PTSD, and now that Health Canada approved phase two of the company’s trial — known as APEX-002-A01-02 — it will begin sending patients home with their doses..“This approval signals a willingness from Health Canada to allow Apex to move forward with a clinical pipeline focused on veteran patients with PTSD and a comorbid diagnosis of depression,” said the company’s chief executive officer, Tyler Powell..Powell highlights veterans, like many others, are already self-medicating with micro-doses of unregulated psilocybin products without knowing the potency and safety of the product they’re consuming..“Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need,” he said..Veterans Affairs Canada estimates up to 10% of war zone veterans were diagnosed with PTSD, and Apex says psilocybin continues demonstrating clinical benefit across a variety of disorders..The compound recently received "breakthrough designation" from the United States Food and Drug Administration for its potential treatment of depression, and Health Canada broadened the special access program in January 2022 to include psilocybin..“It is beyond satisfying to know our team's hard work led to the first Canadian veteran patient taking APEX-52 [psilocybin] in the comfort of their own home,” said Powell..The participating veterans will receive low, multi-dose psilocybin for oral use at home, and the product will be certified by Good Manufacturing Practice.
