MAPS Public Benefit Corporation (MAPS PBC), the nonprofit’s clinical-stage private arm, published new data from its second multi-site, ethno-racially diverse Phase 3 clinical study of MDMA-assisted therapy for PTSD in Nature Medicine.
The randomized MAPP2 study gave participants a split dose, separated by 1.5 to 2 hours, of 80 or 120 mg of MDMA hydrochloride (or placebo,) and following a 40 to 60 mg dose during three therapy sessions. The placebo group received extended therapy sessions.
71% of total 104 participants were assigned female sex at birth, constituting 82% of the placebo group and 60% of the MDMA-assisted therapy group. Participants were also ethnically and racially diverse, 34% identifying as other than White, and 27% as Hispanic/Latino.
Most participants had a comorbid psychiatric disorder and had PTSD for an average of 16 years (28 participants in the moderate form, and 76 in the severe form.)
Results reflect the trial met its primary and secondary endpoints:
86.5% (46) of participants in the MDMA-assisted therapy group experienced a significant reduction in PTSD …