FDA won’t approve psychedelic drug for PTSD

The Food and Drug Administration will not approve MDMA, the street drug known as Molly or Ecstasy, as a treatment for post-traumatic stress disorder, according to a Friday announcement from the maker of the drug, Lykos Therapeutics.

Some lawmakers — even in far-flung Alaska — have used their positions to push the drug, even though recently the studies showed there is not enough evidence to show the drug is effective. Indeed, some study participants said the drug led to suicidal ideation and said their concerns were dismissed by the study managers.

The clinical trial was a hot mess in other ways: There were allegations of sexual misconduct in the middle of the study and there are possible serious side effects like heart problems and drug abuse. FDA scientists also said the study itself was not clean because patients and therapists could easily guess who got the drug and who got the placebo.

Alaska Sen. Forrest Dunbar and Rep. Jennie Armstrong were two of the proponents of MDMA, introducing legislation to set up a task force in Alaska to create a regulatory framework in anticipation of the drug’s approval, which Dunbar falsely said on the record was imminent.

The overeager lawmakers put the cart in front of the horse. Although their legislation passed, it’s not clear the governor will sign it, since MDMA is evidently far from guaranteed approval.

Lykos Therapeutics said it will challenge the FDA decision and says the data is adequate to prove the drug is effective.