What Is MDMA Therapy and What Are Its Risks?

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.

But the agency’s independent advisory panel of experts reviewed studies on June 4, and overwhelmingly decided against endorsing the treatment. Although not required, the F.D.A. often follows the recommendations of its advisory committees.

A final decision is expected in mid-August.

Lykos Therapeutics 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.