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.