North America’s first take home psilocybin trial will be conducted by a pharmaceutical company based in Vancouver. Apex Labs recently announced that it will be conducting the first North American take-home multi-dose psilocybin clinical trial. This patient-driven organization specializes in treatments for military veterans using psilocybin.
On October 24, according to a press release, Apex Labs received a letter from Health Canada stating that they had no objections to the company exploring the efficacy of APEX-52 (psilocybin) for veterans suffering from depression and post-traumatic stress disorder.
Psilocybin that has received Good Manufacturing Practice certification will be given to veteran patients in carefully measured, low doses and instructions on how to take it home.
Apex Labs is the first in North America to be granted approval for a clinical trial involving take-home psilocybin.
The CEO of Apex Labs, Tyler Powell, is ecstatic to introduce this medicine to patients and allow them the opportunity to see if psilocybin can help alleviate their medical conditions in a safe setting. “Receiving this approval from Health Canada means that we can move forward with our clinical pipeline focused on helping Veterans suffering from PTSD who also have a comorbid diagnosis of depression,” said Powell.
“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.”
Psilocybin has been linked with treating numerous conditions and disorders. In 2019, the FDA showed its dedication to fast-tracking drug review and development by giving Usona Institute in Wisconsin the “Breakthrough Therapy Designation” for psilocybin’s potential in treating major depressive disorder.
On Jan. 5, 2022, Health Canada expanded its Controlled Drugs and Substance Act through its Special Access Program to now 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.”
The University of Guelph in Ontario, Canada was recently approved to study psilocybin mushrooms. On October 25th, the school received a “dealer’s license” from Health Canada, making it one of the first universities in North America with such approval.
Soon, American voters will be able to choose whether or not psilocybin should remain illegal. In Oregon, psilocybin was approved via ballot initiative in 2020; however, this year it will be on the ballot again in 27 out of the state’s 36 counties. Meanwhile, lawmakers have adopted the first round of rules for legal psilocybin use in May 2022 with final rules set to be released by December 30th of that same year. As of now, there is a public comment period running from November 1-21st regarding these changes.
Voters in Colorado will also vote on Proposition 122, which would legalize psychedelic drugs and psilocybin therapy centers. According to Kevin Matthews, a military veteran and the coalition director of Natural Medicine Colorado, the passage of this initiative would help many 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,” he said.
“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.”
Last month, Alberta made history by becoming the first Canadian province to regulate psychedelic therapy.
This is all part of a larger trend of change happening around the world. Psilocybin is being decriminalized in many places, with Portugal and the Netherlands leading the way. Psilocybin therapy is also becoming more accepted, with studies being done in the United States, Canada, and Europe.
As more and more people experience the benefits of psilocybin, attitudes will likely continue to change and psilocybin will become more accepted.
