On April 23, 2012, we learned that the U.S. Drug Enforcement Administration had approved the application for a Schedule I MDMA distributor’s license by a contract research firm specializing in synthetic, organic, and medicinal chemistry. This will enable us to transfer the supply of MDMA we use in our U.S. clinical studies to this new facility. The MDMA was originally manufactured in 1985 by Dr. David Nichols at Purdue University, and paid for by MAPS’ predecessor non-profit, Earth Metabolic Design Labs, at a cost of $4/gram. Since Dr. Nichols is retiring from Purdue on June 30, 2012, he will not be able to store the MDMA under his existing Schedule I license after that date. Without an alternative location to store and distribute the MDMA, it would have been destroyed.
Our next step is to identify a facility certified under Good Manufacturing Practices (GMP) that can reprocess the MDMA and certify it as compliant with GMP. Phase 3 trials generally require that investigational drugs be compliant with GMP. The alternative would be to pay to have new MDMA manufactured from scratch. Certifying our existing batch of MDMA as GMP would save MAPS the cost of remanufacturing the drug to be used in our remaining Phase 2 and Phase 3 studies, perhaps as much as $200,000. Obtaining GMP certification for MAPS MDMA would enable us to export it around the world for our international studies, though the facilities storing and distributing the MDMA would need to obtain additional licenses.
