Psychedelic drug researchers can now begin to provide psychiatric patients with psilocybin, the active ingredient in magic mushrooms, as part of their therapy in a groundbreaking FDA approval.
Psilocybin therapy for refractory depression, which affects approximately 50 percent of patients with clinical depression in the United States, was essentially granted by the FDA in a landmark ruling "Breakthrough Therapy Designation" . that the drug has shown significant potential in early clinical trials.
"The Breakthrough Therapy Label Strongly Endorses the Potential of Psilocybin Therapy" Robin Carhart-Harris, head of the psychedelic research group at Imperial College London, said in a press release
The Breakthrough Therapy The name was created in 201
"This is great news for patients, and we look forward to continuing this work with our clinical trial in psilocybin therapy for treatment-resistant depression" George Goldsmith, Compass Executive Chairman, said in a statement.
Researchers have proposed a rescheduling Schedule IV, the category that includes drugs such as Xanax and Ambien. In the context, opioids used as prescription painkillers are currently considered List II medicines; medically helpful but with high potential for abuse
The FDA has not yet issued an official statement on this decision because it cites the confidentiality of breakthrough therapy applications.
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Psilocybin is currently in clinical trials and when it happens, the FDA will be forced to take the restrictive Schedule 1 control status of the drug to change (the most restrictive under US law, classification a
The most notable reclassification debate of recent times followed the groundbreaking approval of Epidiolex, the The FDA recommended the reclassification of marijuana, but the DEA resisted and opted instead to postpone Epidiolex specifically, but no longer.
"We should be aware of that that psilocybin is not without risk of injury " says Matthew Johnson of the Johns Hopkins, ," but relatively speaking, if you look at other l It is the least harmful in various surveys and in different countries.  Do you think your friends would be interested in sharing this story!