Lykos Therapeutics gets FDA acceptance and priority review for an MDMA-assisted therapy NDA for PTSD, with PDUFA set for August 11, 2024

MDMA-assisted therapy for PTSD moved into FDA review after the agency accepted Lykos Therapeutics' New Drug Application for midomafetamine (MDMA) capsules used with psychological intervention. The FDA granted priority review and set a Prescription Drug User Fee Act target action date of August 11, 2024. Lykos says its NDA includes Phase 3 evidence from two randomized, double-blind, placebo-controlled studies (MAPP1 and MAPP2) in people with severe or moderate-to-severe PTSD, using CAPS-5 as the primary endpoint and the Sheehan Disability Scale as a key secondary endpoint. The release also states that no serious adverse events were reported in the MDMA group in either study, and notes that MDMA-assisted therapy has not yet been approved by any regulatory agency.