Apex Labs has been granted approval by Health Canada for the first North American take-home multi-dose psilocybin clinical trial evaluating the safety and efficacy of APEX-52 (psilocybin) in treating depression in veterans with post-traumatic stress disorder (PTSD).
Research shows that psilocybin has demonstrated clinical benefits in a variety of disorders. North American regulatory bodies are now taking necessary steps in accelerating patient access to the medicine, and psilocybin recently received breakthrough designation from the FDA for its potential treatment of depression.
Additionally, Health Canada broadened its Special Access Program (SAP) earlier in 2022 to include psilocybin and MDMA, which enables authorised patients to access the therapy.
Apex Labs has said it is focused on improving access to such therapies for veterans as this is a population disproportionately affected by mental health conditions.
APEX-002-A01-02 is a low-dose, multi-dose, orally administered APEX-52, manufactured under Good Manufacturing Practice (GMP), and currently formulated, packaged, and labeled for self-administered patient dosing in the home.
APEX CEO, Tyler Powell, commented: “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.
“Veterans are already self-medicating 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 drug products through regulated systems, providing transparency and support for patients in need.
“It is beyond satisfying to know that our team’s hard work has led to the first Canadian Veteran patient taking APEX-52 in the comfort of their own home.”
