Apex Labs Granted Approval for North America’s First Take Home Psilocybin Clinical Trial
Apex Labs Ltd., a pharmaceutical company optimizing the standard of mental health care for Veterans, is pleased to announce its approval for the first…
Apex Labs Ltd., a pharmaceutical company optimizing the standard of mental health care for Veterans, is pleased to announce its approval for the first North American take home multi-dose psilocybin clinical trial, APEX-002-A01-02, evaluating the safety and efficacy of APEX-52 (psilocybin) in treating depression in Veterans with Post Traumatic Stress Disorder (“PTSD”). This approval comes by way of a No Objection Letter (“NOL”) from Health Canada received on October 24th, 2022. APEX-52 is a low dose, multi-dose, orally administered psilocybin drug product, manufactured under Good Manufacturing Practice (“GMP”), and currently formulated, packaged, and labeled for self-administered patient dosing in the home.
“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.”Tyler Powell, APEX Chief Executive Officer
Psilocybin has demonstrated clinical benefit in a variety of disorders and North American regulatory bodies are taking necessary steps in accelerating patient’s paths to medical access. Psilocybin 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 (“SAP”) on January 5th, 2022 to include psilocybin and MDMA.
Mr. Powell adds, “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.”
About Apex Labs Ltd
Apex Labs Ltd. is a patient-driven pharmaceutical company focused on optimizing the standard of mental health care for Veterans by bringing data supported, clinically evaluated psilocybin-derived drugs to market for depression in PTSD. APEX is focused on Veterans, who suffer from PTSD at a substantially higher rate than the general public and struggle to find relief from the current inadequate standard of care. APEX’s strategy is focused on developing pharmaceutical products through a robust phased clinical program, while evaluating safety and efficacy in a real-world setting by simultaneously working with Veterans and their primary Health Care Practitioners to develop effective channels to get patients the medical care they need.