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Vancouver has nothing on Toronto ... a city in a constant welfare state of drug addled half wits .....
He obviously hasn’t been to Van City latelyTisme, which city are you describing, Vancouver or Toronto?
I was surprised when I was in Vancouver last year by the number of druggies on the street
Tisme, which city are you describing, Vancouver or Toronto?
I was surprised when I was in Vancouver last year by the number of druggies on the street
Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA
In an extraordinary step forward for the psychedelic drug research community, the US Food and Drug Administration (FDA) has just given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation. This classification suggests the treatment has demonstrated significant potential in early clinical evidence, allowing the FDA to assist and expedite subsequent development and review processes.
The FDA's Breakthrough Therapy designation was created in 2012 as a way of presenting a faster pathway to approval for drugs that display treatment advantages over current options for serious or life-threatening conditions. While not all Breakthrough Therapy treatments may ultimately prove efficacious and make it to market, the designation is generally a positive thumbs-up from the FDA that it's potentially useful and should be expedited.
The specific designation in this instance is directed at a phase IIb trial currently underway across Europe and North America. The research is investigating the optimal dose range for psilocybin in regards to severe treatment-resistant depression. Prior research has found that one to two doses of the psychedelic agent, administered in controlled settings, can markedly reduce a person's depressive symptoms. The safety of these treatments has also been established through earlier research.
The multi-center clinical trial now underway is being run by life sciences company COMPASS Pathways and expands on decades of work by researchers around the world who toiled to push this previously taboo drug into the light of legitimate medical research. Robin Carhart-Harris, head of the Psychedelic Research Group at Imperial College London, has been working for several years to establish the efficacy of psilocybin treatment for depression, and notes that this new FDA designation is a positive sign for the future of psychedelic drug therapy.
"The Breakthrough Therapy designation is a strong endorsement for the potential of psilocybin therapy," says Carhart-Harris. "We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS's multi-center trial."
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