Psilocybin API Import From US To Canada Approved: Here's What You Need To Know

Canadian mental healthcare biopharma company Apex Labs, Ltd. received approval for its new US-based supplier of Good Manufacturing Practices (GMP)-compliant psilocybin Active Pharmaceutical Ingredient (API.)

The company is currently conducting several large-scale, “statistically-powered” multicenter micro-and-macro dose Phase 2b psilocybin clinical trials, producing the synthetic capsules through its primary Canadian-based supplier and now adding the U.S. API provider.  

The new permit, which allows Apex to ship the drug across the border, has been granted by Health Canada (via a Clinical Trial Application amendment) as well as the DEA and U.S. customs.

Apex co-founder and CSO Dr. Orion Lekos called the approval “a large step forward” for the company’s drug development program, as securing a second API manufacturer creates “a sustainable supply of drug product” to support its planned clinical programs in both the U.S. and Canada.

Co-founder and CEO Tyler Powell agreed. "The U.S. represents half of the global pharmaceutical market. Following years of partnership development and effort by the Apex team, this facilitates our ability to successfully execute clinical trials and our Early Access Program in Canada and the U.S. with drug supply established in both markets.” 

Powell further said that Apex’s “positive clinical progression” with Health Canada has allowed the company to begin executing a U.S. regulatory strategy through the filing of an Investigational New Drug (IND) application with the FDA this year.

Apex sees military veterans as a patient base with the most severe 

unmet needs and strong mental healthcare infrastructure and is thus prioritizing support of these patients first, later expanding to broader communities.

The targeted indications for the psilocybin treatments under development include depression and anxiety in PTSD, whether mild, moderate or severe.

One study evaluates multiple regular doses of synthetic oral psilocybin APEX-52 microdose on a take-home basis for depression and anxiety in 294 patients with diagnosed PTSD. 

The other trial evaluates multiple doses of synthetic oral psilocybin APEX-90 macrodose administered in-clinic paired with assisted psychotherapy for severe depression, standalone PTSD symptoms, chronic pain and anxiety in 160 patients.

Photo: Benzinga edit with photo by Cytonn Photography on Pexels and Jynto on Wikimedia Commons.