EE.UU.: Terapia con MDMA para el PTSD rechazada por un panel de la FDA

El panel enfatizó los riesgos y desafíos relacionados con la evaluación de modalidades psicoterapéuticas, estudios ciegos y la seguridad de los pacientes. Más información, en inglés, está disponible abajo.

In a decision that shocked some observers, key advisers to the US Food and Drug Administration (FDA) voted that the effectiveness of the party drug MDMA for treating post-traumatic stress disorder is unproven.

Members of an independent scientific advisory committee voted 9 to 2 that human trials of MDMA did not prove its efficacy. They also voted 10 to 1 that the risks of MDMA, also known as ecstasy, outweigh its benefits. The FDA does not have to follow its advisory committee’s recommendations when deciding whether to approve a drug, but often does.

The vote highlighted the difficulty of assessing psychedelic drugs and the FDA’s limited ability to evaluate psychiatric treatments. “It felt strange to vote no,” says committee member Satish Iyengar, a statistician at the University of Pittsburgh in Pennsylvania, given that the drug’s effects seemed so strong. “There were just too many problems with it.”

The vote took place at a meeting on 4 June in Silver Spring, Maryland.