FDA grants priority review to MDMA-assisted therapy for PTSD

The FDA has accepted and granted priority review to a new drug application for midomafetamine capsules used in combination with psychological intervention for PTSD, according to a press release from Lykos Therapeutics.
The decision was based, in part, on results from the randomized, double-blind, placebo-controlled phase 3 MAPP1 and MAPP2 studies evaluating the efficacy and safety of MDMA-assisted therapy vs. placebo with therapy among patients with severe or moderate-to-severe PTSD.
Both studies met their primary endpoint of changes in PTSD severity from baseline, measured using the

The FDA has accepted and granted priority review to a new drug application for midomafetamine capsules used in combination with psychological intervention for PTSD, according to a press release from Lykos Therapeutics.
The decision was based, in part, on results from the randomized, double-blind, placebo-controlled phase 3 MAPP1 and MAPP2 studies evaluating the efficacy and safety of MDMA-assisted therapy vs. placebo with therapy among patients with severe or moderate-to-severe PTSD.
Both studies met their primary endpoint of changes in PTSD severity from baseline, measured using the