Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD
Lykos Therapeutics a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration has accepted its new drug application for midomafetamine capsules used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with post-traumatic stress disorder (PTSD). The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act target action date of August 11, 2024.