Usona’s Psilocybin therapy for depression approved by FDA breakthrough therapy

The U.S. Food and Drug Administration (FDA) has once again awarded psilocybin (naked mushroom or celosibin) the title of “breakthrough therapy” that is expected to be used to treat severe depression (MDD),media reported. Psilocybin is a psychoactive compound found in many “psychedelic mushrooms”. The title has been awarded to the Usona Institute to enable it to conduct MDD therapy studies based on psilocybin.

Usona's Psilocybin therapy for depression approved by FDA breakthrough therapy

Psilocybin is a psychedelic ingredient that is illegal to own or sell in many countries around the world. In the United States, the compound has the name Schedule 1 and is specifically designed for drugs considered to be highly likely to be abused and not for “acceptable” medical use. The name contradicts the current research institutions surrounding psilocybin, some of which have been found to have high therapeutic uses in people with incurable depression, PTSD and other diseases.

While psilocybin is still a controversial substance, the FDA has acknowledged that it could have potential public health benefits, as reflected in its actions. In late October 2018, for example, the agency named COMPASS Pathways’ psilocybin therapy as a treatment for depression and awarded it the title of “breakthrough therapy.” This itself follows a number of small studies that have revealed that psilocybin may lead to a “substantial improvement” in symptoms in people with depression.

In response, the FDA again awarded the company that uses psilocybin to treat severe depression with the title of “breakthrough therapy.” The Usona Institute announced on November 22that that it had recently launched the second phase of its clinical trial (PSIL201), involving about 80 participants in seven u.S. regions.

It is well known that severe depression is difficult to treat. Despite multiple treatments, many patients report persistent symptoms that severely reduce their quality of life and make it difficult to continue working, care for children, complete school, and many other problems. Some studies have found that the use of a relatively high dose of psilocybin in a clinical setting can lead to long-term remission of depression.

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