Midomafetamine FDA Approval Status
Last updated by Judith Stewart, BPharm on Feb 12, 2024.
FDA Approved: No
Generic name: midomafetamine
Company: Lykos Therapeutics
Treatment for: Post Traumatic Stress Disorder
Midomafetamine (commonly referred to as MDMA or ecstasy) is an empathogen (entactogen) psychoactive in development for the treatment of post-traumatic stress disorder in combination with psychological intervention, including psychotherapy.
- Post-traumatic stress disorder (PTSD) is a serious mental health condition caused by an extremely stressful event. Symptoms include flashbacks, severe anxiety, uncontrollable thoughts, agitation, social isolation, insomnia, and emotional detachment.
- Midomafetamine is MDMA (3,4-methylenedioxymethamphetamine), which belongs to the empathogen (entactogen) class of psychoactive compounds. The U.S. Drug Enforcement Administration (DEA) made MDMA a Schedule I drug under the Controlled Substances Act in 1985, which prevented it from being used for recreational or medical use.
- More recent research has shown that MDMA can act as a powerful catalyst to support psychotherapy by helping diminish the brain's fear response allowing people to access and process painful memories without being overwhelmed.
- In February 2024, Lykos Therapeutics announced that the U.S. Food and Drug Administration (FDA) had accepted the New Drug Application (NDA) for midomafetamine in the treatment of PTSD and granted the application priority review. The Prescription Drug User Fee Act (PDUFA) target action date is August 11, 2024.
- MDMA-assisted therapy is also being investigated for use in in other indications including social anxiety disorder (SAD).
Development timeline for midomafetamine
Further information
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