MDMA rejection poses questions for psychedelic drug trials

Rick Doblin

Source: © John Lamparski/Getty Images

Decision prompts reflection over how psychotherapy is involved, regulating combination treatments and safeguarding patients

The US Food and Drug Administration (FDA) has rejected MDMA as a psychiatric treatment for post-traumatic stress disorder (PTSD). US based Lykos Therapeutics had hoped to get the active ingredient in the club drug ecstasy approved for use in combination with psychotherapy.

Instead, on 9 August, the FDA asked for a further phase 3 clinical trial to collect more data on both safety and efficacy.