PharmAla Biotech Holdings Inc., a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules (including MDMA), has received approval from the US Food and Drug Administration (FDA) for a clinical trial using its LaNeo MDMA Investigational Medical Product (IMP) capsules. This marks the first time the company’s IMP has been approved for trial use in the United States.
Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech, expressed the significance of the FDA approval, highlighting the company’s commitment to maintaining high levels of quality and documentation required by regulatory bodies.
“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 researchers worldwide studying MDMA and also provides Psilocybin through a partnership with Mindset Pharma. In Australia, PharmAla has formed a Joint Venture with Vitura Health to distribute its products.
The company’s CEO, Nick Kadysh, emphasized the FDA’s thorough yet fair evaluation of their materials and processes, and they hope to provide UCLA Researchers with their IMP once relevant permits are issued by the DEA and Health Canada. PharmAla will be showcasing their offerings at the Psychedelic Science 2023 Conference in Denver, where interested researchers can gather more information.
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.