The FDA has officially designated psilocybin as a breakthrough drug. This will make it possible to legally deploy clinical trials of extracts from hallucinogenic mushrooms for the treatment of a serious ailment of our time - chronic depression.
The safety of small doses of psilocybin for the human body has already been officially proven earlier.
The term “breakthrough therapy” was introduced in 2012 as a way to bypass bureaucracy and give doctors a chance to validate controversial treatments in a fast-track manner. This method does not guarantee the appearance of a new drug, but it allows testing exotic methods in a clinical setting if they have real benefits in the treatment of a specific disease. In the case of psilocybin and depression, unofficial research has been going on for decades and its effectiveness has long been proven - in words. Now there is a chance to legitimize this practice.
Some experts are frankly surprised by this move on the part of the state, because the recognition of psilocybin as a reliable medicine will force a redesign of the restrictive protocol No. 1 (Schedule 1 control). It prohibits the importation and distribution of addictive substances into the United States, even if they have great medical potential. When marijuana was officially recognized as a drug and recommended to patients, officials made "exceptions" for the single cannabidiol, Epidiolex, but never changed the protocol.
If psilocybin becomes a medicine, big reforms in American medicine are inevitable, and it will surely ricochet the rest of the world.
Alexander Martynenko