Coker A, Yazar-Klosinski B, Emerson A, Doblin R, Coe M, Henningfield JA
If MDMA is approved for therapeutic use by the FDA, then it must be removed from Schedule I and placed in the most appropriate schedule based in part on analysis of 8 factors listed in the CSA. Although further analyses will be considered for the abuse potential assessment that will be submitted in the NDA, the current evidence does not suggest a high risk of abuse or dependence of MDMA in a clinical setting. This preliminary analysis supports the plausibility of recommendation for rescheduling as no more restrictive than Schedule III.
Presented at the American College of Neuropsychopharmacology 60th Annual Meeting, December 5–8, 2021.