FDA panel to consider psychedelic drug MDMA, or Molly, for PTSD

The Food and Drug Administration’s panel of independent advisors will deliberate June 4 whether to recommend approval of the first MDMA-assisted treatment for post-traumatic stress disorder, Lykos Therapeutics announced Monday.

This would be the first FDA panel of external experts to review a potential new treatment for PTSD in 25 years.

PTSD is a disorder caused by highly stressful events and can significantly disrupt patients’ lives.

Decades of studies have shown that psychoactive ingredients, whether derived from cannabis, LSD or magic mushrooms, have long captivated mental health researchers in their quest for treatments.

In support of its application, Lykos Therapeutics, formerly known as the Multidisciplinary Association for Psychedelic Studies (MAPS), studied the party drug MDMA, more commonly known as ecstacy or molly, in two stage studies advance.

The medication is intended for use in combination with psychological intervention, which includes psychotherapy or talk therapy, and other support services provided by a qualified health care provider.

No psychedelic-based therapies have yet been approved in the United States, but MAPS and companies such as Compass Pathways are testing such drugs to find cures for a range of mental health disorders.