PharmAla Biotech Holdings Inc. has announced contracts to supply its LaNeo MDMA to multiple prestigious institutions, including Mt. Sinai Health System, Harvard Medical School’s McLean Hospital, and Johns Hopkins Medicine, for use in clinical trials. These agreements underscore the growing interest in MDMA-assisted therapies and the increasing demand for clinical-grade MDMA.
Supporting Research at Mt. Sinai
PharmAla will provide its GMP LaNeo MDMA to a clinical trial at Mt. Sinai Health System. Nicholas Kadysh, CEO of PharmAla Biotech, stated, “We’re looking forward to supporting the team at Mt. Sinai Health System with high quality clinical trial drug product. Sinai houses some of the best researchers in the world, executes a significant amount of work for the Veterans Affairs administration (the ‘VA’), and has fantastic new facilities for MDMA-assisted therapy.”
Harvard Medical School's McLean Hospital
McLean Hospital, the largest psychiatric research facility affiliated with Harvard Medical School, has also contracted PharmAla to supply MDMA for a clinical trial. This trial will investigate the mechanistic effects of MDMA in individuals with borderline personality disorder (BPD). Jenna M. Traynor, the principal investigator on the research grant, noted that BPD is a complex disorder with heterogenous symptomology, and as such, could benefit from different treatment options in addition to evidence-based treatments like psychotherapy.
Johns Hopkins Medicine
PharmAla is also contracted to supply MDMA to a clinical trial at Johns Hopkins Medicine. “We’re looking forward to continuing to provide exceptional service – as well as robust investigational drug product – to researchers in the US and around the world,” said Nicholas Kadysh, CEO, PharmAla Biotech.
PharmAla's Role in MDMA Research
PharmAla Biotech focuses on the research, development, and manufacturing of MDXX class molecules, including MDMA. The company emphasizes its commitment to regulatory compliance and high-quality MDMA production. PharmAla has introduced an online tool to help researchers access its MDMA products and adapt their clinical trial protocols to its specifications. According to Kadysh, PharmAla has been contracted to supply MDMA to a large number of academic institutions, including the University of Sydney and the University of Melbourne, in Australia, and the University of California system.
Regulatory Considerations
Due to MDMA’s classification as a Schedule I drug, researchers must obtain licenses from both the U.S. Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) to conduct trials. Because PharmAla is a Canadian company, researchers also need an import permit from the DEA to use their product, and PharmAla must apply for its own export permit from Canadian regulator Health Canada. Kadysh noted that the process of getting approved can take up to three months.
