Toronto, ON March 3, 2025 - PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has completed its shipment of LaNeo™ MDMA to UCLA. The Company believes this is the first such shipment of MDMA capsules to cross the American/Canadian border.
“We are incredibly pleased to have delivered our clinical trial materials to Dr. Bershad and Dr. Marder. Unfortunately, the past 2 years since the signing of our contract have highlighted some of the exceptional difficulties in running a clinical exploring a novel indication with a controlled substance. From addressing ethics committee comments and FDA data requests, to waiting for the Research Advisory Panel of California (RAP-C) to approve the trial,” said Nick Kadysh, CEO, PharmAla Biotech. “I know that the UCLA team has had to work mightily to kick this trial off, and we’ve been glad to do our small part. We’re confident that their work will add significantly to the body of scientific evidence around MDMA, and will be in close coordination to support them if needed.
PharmAla’s LaNeo™ MDMA, which remains the only commercially available MDMA drug product approved by the US Food and Drug Administration (USFDA) for clinical trial use, will be used in this case be used for a clinical trial investigating Schizophrenia. The Company is taking steps to address what it sees as a significant unmet need for MDMA in the United States for clinical trial use, which it hopes to announce in the near future.
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.
Nicholas Kadysh, CEO
press@pharmala.ca