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.