​FDA rejects use of MDMA-assisted therapy in the United States

The US Food and Drug Administration (FDA) has rejected the use of MDMA in therapy in the United States, asking that further studies be conducted before approval.

MDMA-assisted therapy has been under trial for treating PTSD in the US for years, with previous data from studies showing that it could improve mental health when combined with therapy.

Data from the third phase of a clinical trial by US drug company Lykos Therapeutics shows that 71% of those under trial no longer passed PTSD diagnosis after taking the drug therapeutically.

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On August 9, Lykos Therapeutics announced that the FDA had rejected its application to implement MDMA-assisted psychotherapy for PTSD in a major setback.

The FDA demanded further studies to test the safety and efficacy of the trials, which according to Scientific American, could take years to complete and would require significant funding.

In a statement released by Lykos, they explained that the FDA had concerns over “missing data” and the nature of the studies themselves.

“The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” said a statement from Lykos (via The New York Times).

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Lykos said that it will appeal the FDA’s decision, and will also file a complaint to the Committee on Publication Ethics, an organisation that sets guidelines for academic publications.

Speaking to Scientific American, Jennifer M. Mitchell, a neuroscientist who led the phase 3 clinical trials, said that the rejection was “disappointing”.

“From my perspective, I thought we met the criteria that the FDA requested, and I absolutely stand by our data,” she explained.

[Via Scientific American]

Gemma Ross is Mixmag's Assistant Editor, follow her on Twitter