PharmAla's GMP MDMA will be used in the first-ever Phase 3 Trial on MDMA in Australia
VANCOUVER, BC, Aug. 22, 2022 /CNW/ - PharmAla Biotech is proud to have been selected as the MDMA manufacturing partner for the a major Australian Research institute's Phase 3 clinical trial. With the product release of PharmAla's LaNeo™ MDMA earlier this month now complete, researchers across the globe now have a new option to drive their research.
"Having completed our value chain for MDMA here in Canada, we're incredibly pleased to be able to provide it to researchers worldwide," said Nick Kadysh, PharmAla's CEO. "I'm excited to see PharmAla's LaNeo™ MDMA be used for such a vital purpose, and we're glad that our customers continue to find value in our work, alleviating the global supply chain crunch for GMP MDMA."
The total contract value is approximately $175,000 USD. The materials will be delivered in two tranches, with the first tranche expected to be delivered in Q1 of 2023. PharmAla's client has requested anonymity so as not to adversely influence patient recruitment for their clinical trial.
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
press@pharmala.ca