PharmAla Biotech Nabs First-Ever Canadian Approval To Provide MDMA Treatment Outside Clinical Setting

MDXX-class molecules and clinical-grade MDMA developer PharmAla Biotech and distribution partner Shaman Pharma Corp. (affiliated with GMP-compliant CCrest Labs) received Health Canada’s approval to provide proprietary LaNeo MDMA capsules to a Canadian physician for patient treatment under the Special Access Program (SAP.) 

The federal agency has confirmed that this is the first-ever authorization of an MDMA-assisted therapy treatment under the SAP.

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The partnership will not charge the patient or the physician for the drug product. Further, PharmAla will continue delivering an amount of its MDMA capsules for compassionate use under the federal program for the time being. 

Ultimately, the company intends to begin charging patients on a cost-recovery basis. Clinicians seeking to treat their patients with MDMA should submit a request directly to Health Canada’s SAP.

“It’s absolutely thrilling to be able to say that our GMP LaNeo MDMA will be used for the treatment of a patient in Canada. Ultimately, that’s what all of our work should be about improving lives for patients.” said PharmAla CEO Nick Kadysh, adding that “this regulatory milestone” isn’t about financial but rather healthcare impact.

On behalf of Shaman Pharma, CEO Alexandre Grenier added that the authorization marks “a significant step in the evolving narrative of MDMA's potential therapeutic applications,” confirming that this is not a product promotion but rather a testament to the company’s dedication to scientific discovery and advancement in patient care.

Photo: Benzinga edit with photo by Yuriy Golub and Bacsica on Shutterstock.