PharmAla’s GMP LaNeo MDMA has completed all release testing, is ready for export
VANCOUVER, August 17, 2022 (Canada Newswire) – PharmAla Biotech (CSE:MDMA)
(the ‘Company’) has achieved a historic milestone: it is currently the only publicly-traded
company to have produced GMP MDMA at scale. The company believes that it is
currently the only source for commercially-available GMP MDMA other than the
Multidisciplinary Association for Psychedelic Studies (MAPS). With the release of this
large-scale batch of LaNeo MDMA Active Pharmaceutical Ingredient (API),
PharmAla’s GMP value-chain stands ready to support its clinical trial customers and
"After a year of intensive work, we’re thrilled to be able to announce this historic
milestone for the company. As the only GMP MDMA manufacturer in the Americas,
we’re excited to do our part to alleviate the global backlog of clinical-grade MDMA,” said
Nick Kadysh, CEO of PharmAla Biotech, and Chair of the Board of Psychedelics
Canada. "As research into MDMA dramatically increases and a number of countries
begin to move to more permissive ‘expanded access’ regimes, PharmAla Biotech is
perfectly positioned to continue to support scientific discovery by providing the clinical-
grade drug product our research partners need."
PharmAla’s LaNeo MDMA API is scheduled to be formulated into a number of dosage
forms, over the coming number of months, with the first being a 40mg capsule. It can
also be compounded directly by pharmacists, where permitted by local regulations.
"Access to GMP research materials is often a rate liming step in clinical research; but
now with greater access, the science will advance much faster, as will the potential for
improving patient care" said Dr. Leah Mayo, incoming Parker Psychedelic Research
Chair, University of Calgary.
“Over the past 6 months, we’ve heard endlessly about the global supply chain crisis in
Psychedelic molecules. It’s gratifying to now be in a position to assist our partners
worldwide by shipping Drug Substance and Product to them, allowing them to get on
with their vital research,” said Dr. Shane Morris, PharmAla’s COO. “We’re confident
that, once researchers initiate clinical work with PharmAla’s LaNeo MDMA, it will help
drive interest in clinical trials for this impressive drug that several patient groups are
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