Research & Development
FDA accepts NDA for Lykos Therapeutics' midomafetamine capsules for PTSD
12 February 2024 -

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) (Lykos), a mental healthcare company, announced on Friday that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for midomafetamine capsules (MDMA) used along with psychological intervention that includes psychotherapy and other supportive services for individuals with post-traumatic stress disorder (PTSD).

The FDA has offered the application priority review and has allocated a Prescription Drug User Fee Act target action date of 11 August 2024. If the product receives approval, then this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.

Amy Emerson, chief executive officer of Lykos Therapeutics, said, 'Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD. We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.'