FDA Gives Early-Stage Approval for Psychedelic Used to Treat Mental Health Issues

Psychedelics are enjoying a surge of interest from pharmaceutical companies looking to explore their potential for treatment of several mental health issues, from addiction to PTSD. Although the Food and Drug Administration (“FDA”) recently rejected one company’s proposed treatment, as we covered here, that does not mean it’s the end of the road for the industry on the whole, which has invested heavily in the psychedelic space. Recently, the FDA approved an early-stage clinical trial of the psychedelic compound known as “Moxy” to treat depression, anxiety, post-traumatic stress disorder and other mental health conditions. The drug, being used in the study by Mindstate Design Labs, is said to be, “the tofu of psychedelics” by the companies CEO, Dillan DiNardo, due to muted psychedelic effect it has on users in comparison to more commonly known psychedelic drugs such as LSD. The clinical trial aims to see what effect Moxy has on users when combined with other mainstream drugs that treat brain function. Although the drug is most likely years away from FDA approval for widespread use and will be subject to further clinical trials down the line, it is an interesting development in the pharmaceutical world which could have broad implications into drug classification and how society views psychedelics.

AI Played Key Role in Drug’s Development

What may be even more interesting about the drug at issue in the proposed clinical trial is that the psychedelic drug was selected by an artificial intelligence model that analyzed existing data concerning psychedelic trips. Relying on over 70,000 “trip reports” of people across the internet, from respected sources such as clinical trial or books, to the dark web and forums such as Reddit, the AI model used by the company came up with the compound 5-MeO-MiPT, which it identified as most closely targeting mental illness during psychedelic trips. Now that it has the tenuous initial approval of the FDA, we could see a whole new space emerge in research that relies on AI in pharmaceutical development of drugs. Indeed, DiNardo said that, “Moxy is the first part of a number of different medicines that we’ll be making” in relation to the proposed mental health treatments. As AI continues to grow in importance and use in our society, it will be interesting to see what effect it will have on how the government regulates its innovative use and its derivatives.