Approved Study to Examine Tolerability of MDMA in Schizophrenia at UCLA
Vancouver, BC – June 9, 2023 - PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE:MDMA)(OTC:PMBHF), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules (including MDMA), is pleased to report that the US Food and Drug Administration (USFDA) has approved a clinical trial utilizing PharmAla’s LaNeo MDMA Investigational Medical Product (IMP) capsules (40mg). This is the first time that PharmAla’s IMP has been approved for trial use in the United States.
"While we’ve had great success with many regulators around the world, it’s still a major milestone to receive a stamp of approval from USFDA for our investigational drugs,” said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. “As with any IMP supplier, there are always questions about Chemistry, Manufacturing and Control - even for well-known molecules. We believe that this announcement should confirm that our IMP conforms to the high levels of quality and documentation that one of the preeminent regulators in the world requires.
PharmAla supports numerous researchers around the world who are studying MDMA for a diverse series of indications. The company also provides Psilocybin to researchers through their partnership with Mindset Pharma. In Australia, which is allowing treatment of patients with both MDMA and Psilocybin through the Authorized Prescriber Program as of July 1 st , PharmAla has formed a Joint Venture with Vitura Health (ASX:VIT) in order to distribute its products, called Cortexa.
“We found that the FDA scrutinized our materials and processes in a rigorous but fair fashion,” said Nick Kadysh, CEO, PharmAla Biotech. “As with all of our clients, we worked hard to support UCLA Researchers in their application to USFDA. We hope that they are pleased with the results, and look forward to providing them with their IMP as soon as DEA and Health Canada issue the relevant permits.”
The PharmAla team, led by Sales Director David Purcell, will be hosting a booth for potential customers at Psychedelic Science 2023 Conference in Denver for the week of June 19-23. Researchers interested in information regarding PharmAla’s IMP can visit www.PharmAla.ca.
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