The first MDMA-based PTSD treatment is rejected by FDA panel [Video]

One pharmaceutical company’s plans to develop a treatment for Post-Traumatic Stress Disorder using midomafetamine (also known as MDMA, as well as ecstasy or Molly when used as a street drug) have stalled.

This Tuesday the U.S. Food & Drug Administration’s Psychopharmacologic Drugs Advisory Committee voted not to recommend a proposed therapy from California-based Lykos Therapeutics. They asked for more information about therapy services that would be part of the treatment, more lab data and more.

Lykos was seeking approval for the use of midomafetamine capsules in combination with psychological intervention. According to a presentation made at the committee meeting, there was a “statistically significant and clinically meaningful improvement in PTSD symptoms and functional impairment,” across three trials.

Currently, MDMA is considered a schedule I drug by the U.S. Drug Enforcement Agency. That means it has no “currently accepted medical use and a high potential for abuse.”

“Ecstasy/MDMA acts as both a stimulant and hallucinogen, …