Health experts recommend FDA reject MDMA therapy for PTSD

An advisory committee on Tuesday overwhelmingly voted to recommend the Food and Drug Administration (FDA) reject MDMA-assisted therapy for treating PTSD (post-traumatic stress disorder), citing the evidence doesn’t show the drug is effective or safe.

The committee of independent health experts highlighted research gaps, abuse risks, and the unregulated nature of MDMA, also known as Ecstasy.

Even though Lykos Therapeutics’ trials showed improvement in PTSD symptoms, issues like skewed and cardiovascular risks were noted.

The FDA will make the final decision, taking into consideration the advisory committee’s concerns and the urgent need for new PTSD treatments.

If approved, MDMA would be the first psychedelic drug approved for medical use, offering hope to 13 million Americans suffering from PTSD.