FDA Panel Weights MDMA Therapy for PTSD

The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks.

The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy.

Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.

What is MDMA?

Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.

MDMA is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.

In 1985, as the drug became a staple at dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for abuse.