The main ingredient of psychedelic mushrooms is about to become an FDA-approved depression treatment

The active ingredient that makes magic mushrooms so magical – psilocybin, a psychedelic drug – is about to become a legal treatment for difficult cases of depression . This week, Compbad Pathways announced that it has been awarded the Revolutionary Therapy designation by the Food and Drug Administration for its psilocybin-based treatment. The designation will speed up the FDA's review of the treatment for possible approval.

While many people who have taken psilocybin and other psychotropic drugs for recreational purposes can attest to the positive feelings they have left, the research on the possible mental health of these drugs may benefits have been stifled for decades. Psilocybin and other psychedelic substances, such as LSD and DMT, are federally clbadified as Schedule I substances in the United States, meaning they are not considered to have specific uses. medical accepted. In contrast, opioids used as prescription pain medications are Table II drugs, which means that they are recognized as being medically useful, but that they have a potential to be used. high abuse.

But in recent years, doctors, patients and even pharmaceutical companies have started slowly. to convince the government to reconsider its position, with the help of small pilot studies showing that these drugs, usually "microdoses" smaller than a person would take for recreational purposes, can help treat depression , anxiety and even addiction. This is in part what makes the revolutionary designation so important because the FDA also recognizes that a potential drug has some "preliminary clinical evidence" of its alleged effects – effects that could outweigh those any other existing treatment available.

In In the case of psilocybin, studies in the United Kingdom and the United States have shown that it can treat people with depression who do not respond well to other treatments. Compbad is in the process of funding the first large scale psilocybin trial in North America and Europe over the next year, according to the company (the Compbad version of psilocybin is supplied as a powder synthesized in the US). laboratory). The development of this drug is the first major project of the British company founded in 2016.

"This is great news for patients. We are excited to advance this work with our clinical trial of psilocybin therapy for the treatment of treatment-resistant depression, "said George Goldsmith, Executive Chairman of Compbad, in a statement. "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."

This announcement is only the latest of the good news for the field of Psychedelic Medicine.

A nasal spray version of ketamine, an anesthetic and veterinary drug, may soon be approved by the FDA for treatment-resistant depression, as a result of mixed but generally positive results reported in phase 3 clinical trials. The nasal spray version, called esketamine and developed by Johnson & Johnson, received a groundbreaking designation in 2016. And last year, the FDA also granted the status of innovator to a research program using the MDMA (a component of the drug party Molly and Ecstasy). in combination with psychotherapy to treat post-traumatic stress disorder. The program has been developed and is currently undergoing Phase 3 clinical trials with the help of the Multidisciplinary Multidisciplinary Association for Psychedelic Studies (MAPS).

"Just as the FDA granted the title of Revolutionary Therapy for MAPS's MDMA Assisted Psychotherapy Research Program for PTSD, this news further legitimizes the field of psychedelic medicine," he said. to Gizmodo Brad Burge, director of strategic communication at MAPS. E-mail. "The two disruptive therapy designations clearly indicate that psychedelic therapy will likely be the next big paradigm shift in psychiatry."

[COMPASS Pathways]