Press Release: MAPS Places Fully Validated, Multi-Kilogram Synthesis of MDMA in the Public Domain

Press Release: MAPS Places Fully Validated, Multi-Kilogram Synthesis of MDMA in the Public Domain
CANNANNEW REPORT

The full statement MAPS and MAPS PBC have developed the first validated commercial synthetic process for producing multi-kilogram batches of MDMA under current Good Manufacturing Practices The availability of larger quantities of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use following anticipated regulatory approvals Publication of this process establishes “prior art,” contributing to MAPS’ patient access strategy by making intellectual property public  MDMA is a promising psychedelic compound, currently placed by the Drug Enforcement Administration (DEA) in Schedule I of the Controlled Substances Act, that has been produced for legal research in small batches by certified laboratories. An increasing interest in clinical study of the 110-year-old compound, combined with anticipated regulatory approvals of MDMA-assisted therapies, necessitate the development of a multi-kilogram current Good Manufacturing Practices (cGMP) production process by the leading research sponsor, the Multidisciplinary Association of Psychedelic Studies (MAPS), and trial organizer, MAPS Public Benefit Corporation (MAPS PBC). “Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA” recently published in ACS Omega, a journal of the American Chemical Society, is the first paper to describe a fully validated cGMP synthesis of up to 5 kg (≈30,000 patient doses) of MDMA in a four-step process beginning with a non-controlled starting material. Based on our commitment to Open Science, adopted to promote scientific advances and patient access, MAPS Public Benefit Corporation (PBC) is sharing our manufacturing achievement for commercial production of MDMA with the scientific community. We are at the forefront of MDMA research, and our Open Science practices have been pushing the nascent field of psychedelic-assisted therapeutics forward for the last four decades. Jay B. Nair, Ph.D., P.M.P., lead author and MAPS PBC Head of Chemistry, Manufacturing, and Controls The manufacture methods of MDMA at a laboratory scale were originally placed in the public domain by Alexander Theodore Shulgin, Ph.D., Ann Shulgin,…

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Source : Press Release: MAPS Places Fully Validated, Multi-Kilogram Synthesis of MDMA in the Public Domain

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