A panel of US health experts convened by the Food and Drug Administration on Tuesday overwhelmingly voted against the use of MDMA, commonly known as ecstasy, to treat post-traumatic stress disorder.
PTSD, a debilitating mental health condition that develops after a person experiences or is threatened by traumatic events such as death, combat or sexual assault, affects an estimated five percent of Americans in any given year.
But pharmaceutical treatment options are so far limited to two antidepressants that require three months of dosing to take effect, and response rates to the medications have been found to be uneven.
California-based Lykos Therapeutics has based its request for regulatory approval on two clinical studies, each of which enrolled around 100 people, to evaluate MDMA used together with other psychological interventions such as talk therapy, against a placebo with talk therapy.
These two studies, published in the prestigious journal Nature Medicine, indicated MDMA was indeed both safe and highly effective at treating PTSD.
But nine out of 11 experts on the panel said available data was not enough to show the treatment was effective, and 10 out of 11 said the benefits did not outweigh the risks.
“I think this is a really exciting treatment. I’m really encouraged by the results to date,” said one of the experts, Paul Holtzheimer of the National Center for PTSD.
“But I feel that both from an efficacy and a safety standpoint, it is still premature.”
The vote by the panel of experts is non-binding, but the FDA rarely goes against their recommendations.
