North America’s First Take Home Psilocybin Trial Approved in Canada

Participants will be allowed to take home psilocybin in a study examining its effects on depression and post-traumatic stress disorder.

A pharmaceutical company called Apex Labs announced on Nov. 1 that it will be conducting the first North American take home multi-dose psilocybin clinical trial. Apex Labs is a patient-driven pharmaceutical company that specializes in psilocybin treatments for military veterans.

According to a press release, the trial known as APEX-002-A01-02 will explore the efficacy of APEX-52 (psilocybin) for veterans suffering from depression and post-traumatic stress disorder. Apex Labs received a “no objection letter” from Health Canada on October 24.

The veteran patients will receive low-dose, multi-dose psilocybin for oral use, which received Good Manufacturing Practice certification, and will be given to patients in a labeled package with at-home instructions.

Apex Labs CEO Tyler Powell is excited to introduce this medicine to patient participants, allowing them a safe way to explore if psilocybin can help treat their medical conditions. “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,” Powell said. “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.”

There’s evidence that psilocybin can be effective in treating numerous conditions and disorders. In 2019, the U.S. Food and Drug Administration (FDA) gave “Breakthrough Therapy Designation” to Usona Institute in Wisconsin for its work on psilocybin to treat major depressive disorder. Such a designation shows that the FDA is committed to fast tracking drug review and development.

Similarly, on Jan. 5, 2022, Health Canada amended its Controlled Drugs and Substance Act through its Special Access Program, expanding to include psilocybin and MDMA. “There has been emerging scientific evidence supporting potential therapeutic uses for some restricted drugs, most notably psychedelic restricted drugs such as MDMA and psilocybin that have been granted “breakthrough therapy” designation by the United States Food and Drug Administration for the treatment of post-traumatic stress disorder and treatment-resistant depression, respectively,” Health Canada wrote.

Powell is proud of the opportunity his team will have to help veterans in this first-ever at-home trial. “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,” Powell said. 

Just recently, the University of Guelph in Ontario, Canada was approved to conduct a study on psilocybin mushrooms. The university received a “dealer’s license” from Health Canada on Oct. 25, making it one of the first universities in the country to receive such approval.

In the U.S., voters will soon choose whether or not to approve psilocybin. In Oregon, psilocybin was approved via ballot initiative in 2020, but this year it will be on the ballot again in 27 of the state’s 36 counties. Meanwhile, the Oregon Health Authority recently adopted the first round of rules for psilocybin in May 2022, and the final rules are set to be adopted by December 30, 2022. There is currently a public comment period running from Nov. 1-21.

Voters in Colorado are also voting on psychedelic legalization and psilocybin therapy centers with Proposition 122. According to military veteran Kevin Matthews, who is also the coalition director of Natural Medicine Colorado, believes that the approval of this initiative would help countless people. “They changed my life. The clouds parted. I realized that I no longer had to be a victim to my diagnosis of major depression,” Matthews told the Colorado Sun. “Colorado is in a mental health crisis right now. We want to make sure that all Coloradans have access to this at some level, especially our veterans and those with extreme trauma.”

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