US health authority temporarily rejects MDMA treatment for PTSD

US health authorities on Friday rejected an application for the drug MDMA, better known as ecstasy, to treat post-traumatic stress disorder (PTSD), saying more research is needed.

The company that filed the application, Lykos Therapeutics, said in a statement that the Food and Drug Administration (FDA) had requested an additional Phase 3 clinical trial to investigate the “safety and efficacy” of MDMA.

An expert panel assembled by the FDA to review clinical data on MDMA voted overwhelmingly in early June that there was insufficient evidence to demonstrate its effectiveness.

While not a surprise, the decision announced Friday is a blow to advocates of the new treatment.

“The FDA’s request for another study is deeply disappointing, not only for all those who have dedicated their lives to this groundbreaking endeavor, but especially for the millions of Americans with PTSD… who have not seen new treatment options in more than two decades,” said Lykos CEO Amy Emerson.

PTSD is a debilitating mental health condition that develops after a person experiences or is threatened with traumatic events, such as death, combat, or sexual abuse.

It is estimated to affect five percent of Americans each year.

Pharmaceutical treatment options for PTSD are currently limited to two antidepressants that take three months to take effect. In addition, response rates to the drugs appear to be variable.

MDMA (methylenedioxymethamphetamine) is a Schedule 1 drug under the Controlled Substances Act, and approving it for medical use would be a major change.

California-based Lykos based its request for approval on two clinical trials, each involving about 100 people, evaluating MDMA in combination with other psychological interventions, such as talk therapy, versus a placebo in combination with talk therapy.

These two studies, published in the prestigious journal Naturopathyindicated that MDMA is indeed safe and highly effective in treating PTSD.

However, nine of the 11 experts on the FDA panel said the available data were not sufficient to show the treatment was effective, and 10 of the 11 said the benefits did not outweigh the risks.

In a briefing document prepared ahead of the meeting, FDA officials raised concerns about Lykos’ clinical trial methodology and criticized the company for not collecting enough data on adverse events.

The company said it “will work diligently in the coming months to address the FDA’s concerns and will use the agency’s procedures to resolve scientific disagreements.”

“We plan to work tirelessly and use all available regulations to find a reasonable and expeditious path forward,” Emerson added.

© 2024 AFP