MDMA therapies hit a roadblock – what’s next?

Grace Wade in New Scientist:

Roughly one year ago, thousands of people gathered in Denver, Colorado, for the largest psychedelic conference in history. The mood was electric, with most attendees confident that the US Food and Drug Administration (FDA) was on the verge of approving its first psychedelic drug.

But last week, the FDA dealt a devastating blow to supporters of psychedelic therapies. It rejected the hallucinogen MDMA as a treatment for post-traumatic stress disorder (PTSD), citing concerns about safety and the validity of clinical trial results. The decision is a pivotal moment for psychedelic science and raises questions about what – if any – future these drugs have in medicine.

The California-based company Lykos Therapeutics has published two phase III clinical trials showing that MDMA, along with talk therapy, significantly improved symptoms of PTSD. The trials, which involved almost 200 adults with moderate-to-severe PTSD, found that between 33 and 46 per cent of those treated with three doses of MDMA were in remission from the condition two months later. The same was true for less than a quarter of the trial participants who had received only talk therapy.

At face value, these results are remarkable.

More here.

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