FDA Gives Psilocybin Clinical Studies Breakthrough Therapy Status
The FDA recognized psilocybin, the psychoactive compound in magic mushrooms, with “Breakthrough Therapy” designation for clinical trials studying its use for treatment-resistant depression by a company called Compass Pathways. The group plans to treat patients in Europe and North America over the next year in placebo-controlled studies to determine proper dosage and treatment methods.
Since hallucinogenic drugs were given Schedule I designation in 1966, psilocin and psilocybin have been villainized by the media and politicians who claim it has a high potential for abuse and no medical application. But recent studies from esteemed research institutions, including Johns Hopkins and London’s Imperial College, have helped ease misconceptions and stigma surrounding the drug, and now government regulatory bodies are seeing its potential.
Compass Pathways, a life sciences company founded in 2016 whose focus is to “accelerate patient access to evidence-based innovation in mental health,” specifically through research with psilocybin, was given the go-ahead by the FDA back in August, but the recent designation was an unexpected acknowledgment, according to some of those involved in its research.
According to the FDA, “Breakthrough Therapy” means it reviewed the findings of researchers it granted use of the drug to and viewed their results as:
“Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”
Once this designation is given, the FDA expedites the development and review of the drug, hopefully allowing medical professionals to soon begin implementing it as a legal, viable treatment and eventually change the scheduling of the drug.
Dr. Roland Griffiths, one of the foremost researchers in government-sanctioned studies of hallucinogenic drugs, told Inverse he’s hopeful the regulatory approval will change, though he doesn’t envision it becoming available from a pharmacy anytime soon, if ever.
Griffiths and his colleagues have mostly advocated for its use in controlled settings with guided sessions from a trained psychologist. He’s also stated he believes it can be a dangerous drug when taken by those with certain pre-existing mental illnesses, notably schizophrenia.
But now that studies have shown psilocybin to act as a “reset mechanism” in the brain for those suffering from severe forms of depression, this latest recognition from the FDA may allow psilocybin treatment to become available for those desperately needing it. This breakthrough may also pave the way for FDA trials with other psychedelic substances, such as LSD, currently studied by Griffiths and others in his field.
For more on Dr. Roland Griffith’s and other cutting edge work studying clinical treatments with psychedelic substances, check out this episode of Psychedelica:
Psilocybin and Depression; Psychedelics Can Reset Brain Function
Psychotropic plants once considered taboo are now being used as highly effective clinical solutions for treating a number of psychological issues, including depression, PTSD, and end-of-life anxiety.
And recent studies have gained traction using psilocybin, the psychoactive compound in ‘magic’ mushrooms, as a successful treatment for depression. The study found evidence of a reset mechanism in the brain triggered by psilocybin that can have lasting effects.
Psilocybin & Depression
A calm, relaxed feeling in the hours, days, and weeks after using psilocybin is familiar to those who have taken it before. This is sometimes referred to as an “after-glow,” and many attribute this to the sense of profundity or universal insight acquired during the experience. This sensation is often subjective and fleeting – something that would be difficult to measure in a lab.
But now a team of researchers has set out to measure this feeling and the potential it has for use as a clinical treatment for depression and anxiety. These researchers believe they have possibly recorded this reaction and noticed a reconfiguration of the neural pathways in patients, which they say have become narrowly reinforced in people experiencing severe depression and anxiety. Their research appears to show what they call a disintegration and reintegration in which psilocybin acts as a “reset mechanism.”
This test, conducted by researchers at Imperial College London, looked not only at subjective measures of how patients felt in the days and weeks after receiving a dose of psilocybin but also more objective measures seen in brain scans that monitor cerebral blood flow and functional connectivity. The scientists focused on the amygdala, an area of the brain where emotion, behavior, and motivation are processed, noticing that decreased cerebral blood flow to this particular location correlated with reduced depressive symptoms.
The amygdala is directly connected to the prefrontal cortex, controlling a sort of back and forth process for measuring fear. This is basically where your fight or flight response plays out. The amygdala acts as our alarm system, sending a signal to the prefrontal cortex, which in turn tells it whether that threat is something to actually be concerned about. It’s thought that higher activity in the amygdala leads to lower activity in the prefrontal cortex which causes anxiety and depression.
This has led scientists to see psilocybin as an appropriate medicine for people experiencing anxiety and depression. But psilocybin isn’t the only psychedelic shown to have this effect. And while these material observations seem to correlate things like blood flow and electrical activity with those positive changes, some still maintain that the mystical psychedelic experience rather than the plant is what is so palliative.