The Food and Drug Administration has granted the ‘Breakthrough Therapy’ designation to the treatment of major depression disorder (MDD) using psilocybin, the psychoactive compound found in many mushrooms collectively referred to as ‘magic mushrooms.’ The designation was granted to Usona Institute, enabling it to proceed with an investigation into psilocybin-based treatment for MDD.
Psilocybin is a psychedelic that remains illegal to possess or sell in many countries around the world. In the United States, the compound has a Schedule 1 designation, which is reserved for drugs considered to have a high potential for abuse and no ‘accepted’ medical use. That designation remains at odds with the body of research that currently exists surrounding psilocybin, some of which have found a high potential for therapeutic use in people suffering from treatment-resistant depression, PTSD, and more.
Though psilocybin remains a scheduled substance, the FDA has acknowledged the potential benefits it may have on public health, something reflected in its actions. In late October 2018, for example, the agency granted ‘breakthrough therapy’ designation to the use of psilocybin as a depression treatment to COMPASS Pathways. That itself followed small studies that revealed the potential for psilocybin to trigger ‘substantial improvement’ in the condition of depressed individuals.
In keeping with that trend, the FDA has once again granted a ‘breakthrough therapy’ designation to a company for the use of psilocybin to treat major depression disorder. Usona Institute announced on November 22 that it recently launched the second phase of its clinical trial (PSIL201) involving around 80 participants across seven sites throughout the United States.
Major depression disorder is notoriously difficult to treat; though there are multiple authorized treatments in existence, many sufferers report continued symptoms that drastically decrease their quality of life, make it difficult to keep employment, take care of their children, finish schooling, and a number of other issues. Some studies have found that a single relatively high dose of psilocybin administered in a clinical setting can cause long-term remission of the depression.