The US Food and Drug Administration (FDA) has granted priority review for an application seeking to use MDMA (commonly known as ecstasy) for the treatment of post traumatic stress disorder (PTSD).
Lykos Therapeutics, a company dedicated to “transforming mental healthcare”, announced recently that the FDA has accepted its new drug application (“NDA”) for midomafetamine capsules (“MDMA”) 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 (“PDUFA”) target action date of August 11, 2024.
If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.
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