The availability of larger quantities of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use following anticipated regulatory approvals.
MAPS has placed its fully validated, multi-kilogram synthesis of MDMA in the public domain. It has developed the process under current Good Manufacturing Practices with MAPS Public Benefit Corporation (PBC).
MAPS states that an increasing interest in clinical study of MDMA, combined with anticipated regulatory approvals of MDMA-assisted therapies, necessitate the development of a multi-kilogram current Good Manufacturing Practices (cGMP) production process.
“Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA” has recently been published in ACS Omega, a journal of the American Chemical Society. It is the first paper to describe a fully validated cGMP synthesis of up to 5 kg (around 30,000 patient doses) of MDMA in a four-step process beginning with a non-controlled starting material.
Jay B. Nair, PhD, PMP, lead author and MAPS PBC head of Chemistry, Manufacturing, and Controls, commented: “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.”
MAPS stated that the chemical purity of the final product exceeded 99.9 per cent in each of the four validation trials with an acceptable yield.
Berra Yazar-Klosinski, PhD, contributing author and MAPS PBC Chief Scientific Officer, commented: “Promising clinical trial results have generated much interest in studying MDMA as a catalyst to therapy for PTSD and related conditions — and an increased demand for pharmaceutical-grade MDMA.
“This cGMP-compliant production process will supply the ongoing Phase III and investigator-initiated trials and will ameliorate existing supply constraints for the broader research community. As we approach our anticipated FDA approval in 2023, the availability of cGMP-compliant MDMA will be secured for future therapeutic use.”
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