The Food and Drug Administration is likely to approve a phase three clinical trial of MDMA-assisted psychotherapy, according to the Multidisciplinary Association for Psychedelic Studies (MAPS), which met with the agency on May 11. A successful phase three trial–i.e., a randomly controlled, double-blinded study that demonstrates both efficacy and safety in a large patient population–would all but guarantee the drug's eventual removal from schedule I of the Controlled Substances Act.
"At the meeting, all of the FDA's concerns were addressed and no outstanding questions remain," MAPS reported after its sit-down with the FDA earlier this month. "There are no roadblocks to moving forward with Phase 3 as the FDA gave favorable feedback to MAPS and [MAPS Public Benefit Corporation's] responses to FDA questions."
The FDA will share official minutes with MAPS in mid-June, after which the group will re-submit its protocol and Statistical Analysis Plan. It expects both will be approved without objection.
The phase three trial for MDMA-assisted psychotherapy as a treatment for PTSD is expected to cost approximately $25 million, of which MAPS has already raised $10 million (none of it from government agencies or pharmaceutical companies.)
There's a lot at stake here. In addition to the outrageous criminal penalties associated with schedule I substances, MDMA has incredible potential as a treatment for a range of central nervous system disorders:
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