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Earlier this week, Puerto Rico put itself on the psychedelics-related policy map when Governor GonzĆ”lez-ColĆ³n signed an Executive Order directing the Secretary of its Department of Health to explore ways to catalyse psychedelic research on the island, including via a potential pilot program.
Elsewhere, Montana has launched its experimental drug access pathway that allows biotechs to sell drugs that have cleared Phase I, if theyāre accepted by a newly established review board. As with Right to Try, however, many drug developers will be hesitant to operate in such a program.
Indeed, the primary goal of psychedelic drug developers remains FDA approval, an elusive goal that now seems closer than ever for sponsors like Compass Pathways, Usona Institute, and Resilient Pharmaceuticals, whose MDMA new drug application has now been resubmitted to the agency, we understand.
While much of the focus continues to be on launch-readiness in the U.S., a study that published in Nature Medicine earlier this week sets the scene for psilocybin therapy in Englandās National Health Service (NHS) setting. That trial, which was positive, was the first publicly funded trial in the UK, too, and used Compass Pathwaysā COMP360 psilocybin. Still, launching psychedelic therapies in the UK is a tall ask, as we have seen with other interventional psychiatry treatments like TMS and, perhaps most relevantly, Spravato, which remains unavailable through the NHS.
While it does seem full steam ahead, at least in the U.S., we are also presented with reminders regarding the power of these substances. Another arrived this week, as journalist Kimon de Greefās new book, āThe Ego Tripā, published. It charts the history, mythology, and economy surrounding the Sonoran Desert toad and the drug, 5-MeO-DMT, its venom contains. His reporting explores just how dramatic patient and client experiences can be, again raising questions around precisely how psychedelics should, or will, be integrated into our healthcare systems.
Over at Psychedelic Alpha, weāre continuing to look for ways to improve your experience. In response to reader requests, this week we rolled out the option to listen to our PĪ±+ Psychedelic Bulletins. Audio is generated using artificial intelligence, though the voice model is trained on my own.
We will be rolling out more audio soon, in an effort to help you stay current as we all continue to be busier than ever!
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
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