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Psychedelic drug researchers can now begin to provide psychiatric patients with psilocybin, the active ingredient in magic mushrooms, as part of their therapy, as part of a landmark US Food and Drug Administration (FDA) approval.
Psilocybin treatment for treatment-refractory depression, which covers approximately 50% of patients diagnosed with clinical depression in the United States, has "Breakdown therapy designation" by the FDA in a landmark decision, essentially admitting that the drug has shown significant potential in early clinical evidence.
"The designation of rupture therapy is a strong recognition of the potential of psilocybin therapy," In a press release, Robin Carhart-Harris, head of psychedelic research group at Imperial College London
The disruptive therapy designation was created in 2012 to accelerate the approval of drugs that have a distinct advantage over currently available alternatives for treating serious or life-threatening conditions. While this does not necessarily guarantee that a drug will be on the market, this indicates that the administration believes that further research would be beneficial.
"It's great news for patients. We are pleased to continue this work with our clinical trial of psilocybin therapy for treatment-resistant depression ", said George Goldsmith, executive chairman of Compass, in a statement.
The researchers suggested rescheduling Schedule IV, a category that includes drugs such as Xanax and Ambien. For the context, opioids used as prescription painkillers are currently considered Schedule II drugs; medically useful, but with the potential for high abuse.
The FDA has not yet made any official comment on the decision, citing the confidential status of disruptive therapy applications.
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Psilocybin is currently undergoing clinical trials and, if successful, the FDA will be required to change the restrictive status of Schedule 1 of the drug (the most restrictive under US law, classifying a drug as causing high dependence and no medical use).
The most notable debate over the reclassification of recent years took place after the historic approval of Epidiolex, the very first marijuana-derived drug. The FDA has recommended the reclassification of marijuana, but the DEA has resisted, preferring instead to postpone the treatment of Epidiolex, but nothing more.
"We should be clear that psilocybin is not without risks, which are more serious in a recreational setting than in a medical setting,"says Matthew Johnson of Johns Hopkins, "But relatively speaking, looking at other drugs both legal and illegal, it turns out to be the least harmful in different surveys and in different countries."
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