The U.S. Food and Drug Administration (FDA) has given the green light to a clinical trial investigating the use of 3,4-methylenedioxymethamphetamine, commonly known as MDMA, in patients with schizophrenia. This experimental medical product (IMP) has been developed by PharmAla Biotech, a Canadian firm, and the trial will be conducted by researchers at the University of California, Los Angeles (UCLA).
Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech, expressed delight at the FDA’s approval, which she described as a significant milestone for the company’s investigational drugs. She reiterated the company’s commitment to meeting high standards of quality and documentation required by top regulators globally.
PharmAla is well-known for supporting MDMA research across various medical fields worldwide. In addition to MDMA, they supply Psilocybin to researchers through a partnership with Mindset Pharma. In Australia, where the usage of both MDMA and Psilocybin for patient treatment is becoming legal through the Authorized Prescriber Program, PharmAla has joined forces with Vitura Health to distribute its product line, Cortexa.
Nick Kadysh, CEO of PharmAla Biotech, appreciated the rigorous scrutiny the FDA applied to their materials and processes, stressing the company’s commitment to assisting the UCLA researchers in their FDA application. He expressed hope for the successful outcome of the trial upon receiving the necessary permits from DEA and Health Canada.
In order to engage with potential clients and stakeholders, PharmAla is set to participate in the upcoming Psychedelic Science 2023 Conference in Denver, hosted from June 19-23. Led by Sales Director David Purcell, the PharmAla team will provide information about their IMP to interested researchers.