MDMA therapy for mental health in the spotlight

An FDA panellist thinks MDMA for treating PTSD is “not ready for prime time” but remains hopeful.

Last week, the US Food and Drug Administration (FDA) declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD) based on data submitted by the developer, Lykos Therapeutics. 

Many have criticised the FDA’s decision, arguing that MDMA-assisted therapy has shown tremendous promise in treating PTSD and could be a game-changer for patients.

Notable figures such as presidential hopeful Robert F Kennedy Jr tweeted that it was a “scandalous decision” by the FDA to reject the approval, predicting it “will have deadly consequences.”

Time Magazine ran an article by PTSD sufferer Christina Musk, who argued persuasively for the approval of MDMA therapy after she was harmed by traditional psychiatric treatments.

MDMA is a mind-altering drug, commonly known as ecstasy or molly, and is currently illegal in the US. So far, the FDA has never approved it for therapeutic purposes.

In contrast, Australian regulators recently approved MDMA and psilocybin for restricted therapeutic purposes in a controlled medical setting, and patients have been receiving treatment since January 2024.

A resurgence in the interest of psychedelic drugs for treating mental health conditions was spurred by a study published in Nature Medicine in 2023.