Magic mushrooms named by the FDA a "revolutionary therapy" against depression

Psilocybin, the chemical substance of the "magic mushroom", has been called revolutionary therapy by the FDA, accelerating research on its use to treat depression.

The designation was introduced in 2012 and is reserved for treatment for life-threatening serious conditions that may be better than existing ones.

According to the Drug Enforcement Administration (DA), psilocybin is an add-on drug, but it and several other psychedelic drugs have recently gained ground as promising treatments for mental illnesses.

In August, a psilocybin test was approved for the first time by the FDA.

The results of the trial so far seem to have been so promising for patients with treatment-resistant depression that the agency has assigned it a rare classification, which could halve the time needed to obtain approval.

Psilocybin, the active chemical substance in psychedelic "magic mushrooms", has proven so promising for the treatment of depression that the FDA has now qualified it as a revolutionary therapy, which should accelerate the development of the drug. drug.

Depression is extremely common in the United States, but many patients never feel able to find an effective treatment.

Some 40 million adults suffer from depression or a form of depression. It is widely believed that a combination of speech therapy and medication is more beneficial to the majority of people. Depressed patients, but even the two-part attack fails for many.

Between 10 and 30% of these people do not find relief from traditional medications, such as selective serotonin reuptake inhibitors (SSRIs).

There are about 10 other classes of antidepressants, but for some patients they fail.

And even when they work, patients can take months to feel the effects and this relief can lead to unpleasant – and sometimes unbearable – side effects such as nausea, insomnia, and sexual dysfunction.

Psilocybin is radically different from these existing treatments.

While SSRIs and other approved antidepressants are supposed to act by making the emotional center of the brain, the amygdala, less susceptible to intense negative feelings.

Psilocybin seems to do the opposite.

Psilocybin seems to encourage emotional activity in the amygdala during brain scans of patients treated with the experimental treatment of depression.

However, patients are then better able to manage these feelings and relieve themselves of their depressive symptoms a few weeks later.

Other research has suggested that the drug "resets" neural circuits that create negative feedback loops in the patients' brains.

The growing body of evidence supporting the utility of psilocybin has led the FDA to give Compass Pathways, supported by Peter Thiel, the green light to expand its clinical trial of the compound in the United States in August.

Compass was then about to start a trial in the UK and would soon start testing in Canada and the Netherlands.

Billionaire Peter Thiel Supports Compass Pathways and Psilocybin Treatment for Depression

Just three months later, the FDA has designated psilocybin as a revolutionary therapy, a distinction that should shorten the time between its ongoing trials and wider patient access to therapy.

This decision has a number of important implications for psilocybin and depression itself.

First and foremost, the FDA only gives a revolutionary classification for therapies "intended to treat a serious or life-threatening illness or condition," according to the agency's website.

Only recently has depression been widely treated as a medical condition. Now, the FDA considers that it is "serious or life threatening," indicating a shift in perspective on its severity.

Psilocybin is not the first treatment for depression to have been designated as a breakthrough, but it is unique and is a bit of a bureaucratic puzzle.

At present, the DEA ranks it among the drugs of Schedule I, which means that, like heroin, it has demonstrated medical uses.

But now, the FDA, another government agency, says the opposite.

In addition, by calling psilocybin a revolutionary therapy, the FDA promises to accelerate its development.

On average, it takes about 12 years to get an FDA approved drug. Being designated as a rupture therapy reduces this time to 5.7 years, less than half the time required.

The designation also indicates that psilocybin may actually be more effective in treating some of the more difficult cases of depression than drugs already on the market.

In a statement, George Goldsmith, chairman of the board of Compass Pathways, described the designation as "good news for patients."

"We are excited to advance this work with our clinical trial of psilocybin therapy for treatment-resistant depression.

"The FDA will work closely with us to speed up the development process and increase the chances of getting this treatment for people with depression as quickly as possible."