Complete Response Letter NDA 505b1 215455 (Aug 8, 2024)
The FDA issued a complete response letter for NDA 215455, citing substantial concerns regarding the reliability of safety data due to inconsistent adverse event reporting, particularly for 'positive' effects related to abuse potential. The application also failed to demonstrate durable treatment effects for midomafetamine in PTSD, largely due to design issues and potential selection bias in the MAPP1, MAPP2, and MPLONG studies. The FDA recommends a new clinical trial to address durability and safety characterization, including specific design elements to minimize bias and ensure comprehensive AE capture. Additionally, the FDA identified data gaps in laboratory assessments, cardiac safety, and hERG evaluation that need to be addressed in any resubmission, along with recommendations for characterizing psychotherapy's contribution and improving study diversity.
