Press Release

PharmAla Biotech and Shaman Pharma Granted First Ever Special Access Program Authorization for MDMA

This authorization is the first authorized treatment of a patient with MDMA outside of a clinical trial in Canadian history

VANCOUVER, British Columbia, May 16, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules (including MDMA) and its distribution partner, CCrest Laboratories (operating as Shaman Pharma, “Shaman”) have received an authorization to provide a number of its LaNeo MDMA capsules to a Canadian physician for treatment of a patient under Health Canada’s Special Access Program. PharmAla has confirmed with Health Canada that this is the first-ever authorization of an MDMA-assisted therapy treatment under the Special Access Program.

“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 Nick Kadysh, CEO of PharmAla. “This regulatory milestone isn’t about financial impact, but healthcare impact.”

PharmAla and Shaman will not be charging the patient or the physician for the drug product, which will be delivered on a compassionate-use basis. PharmAla will continue making available an amount of drug product for compassionate use under SAP, but ultimately plans to begin charging patients on a cost-recovery basis. Clinicians seeking to make a Special Access Program request for MDMA for their patients should submit a request directly to Health Canada’s Special Access Program.

Alexandre Grenier, CEO of Shaman Pharma, commented: "Working in concert with PharmAla Biotech on this historic authorization, we've marked a significant step in the evolving narrative of MDMA's potential therapeutic applications. But let's be clear: this is not a product promotion. It's a testament to our unwavering dedication to scientific discovery and advancement in patient care. As we take part in this landmark moment alongside PharmAla Biotech, our commitment is not just to follow progress, but actively lead it."

PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the first company to make available to researchers two clinical-grade Psychedelic APIs: its. LaNeo MDMA, and GMP Psilocybin manufactured by Mindset Pharma. Shaman Pharma will be distributing all Special Access Program requests for PharmAla.

PharmAla will be hosting a webinar regarding its newly-formed Joint Venture in Australia, Cortexa, on the evening of May 16, 2023 at 7:00 Eastern Time. Those interested in learning more can register here:

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

Media Inquiries

Nicholas Kadysh, CEO