Over 17 million people suffer from major depressive disorder (MDD) in the United States. Of them, 45 percent suffer from treatment-resistant depression, which is diagnosed when at least two types of therapies have failed to make a difference. The Food and Drug Administration (FDA) has recognized that more research is needed to address this widespread disorder and newer drugs need to be discovered.

Therefore, the agency has granted the Breakthrough Therapy Designation to psilocybin, a psychoactive and hallucinogenic compound found in magic mushrooms. The nonprofit organization Usona Institute is testing its efficacy to treat depression symptoms. Generally, the status can be given to drugs before the phase 2 of the clinical trial is nearing its end. This is to help expedite the approval procedure and make the medicine available faster to deal with the crisis at hand.

Accordingly, Usona’s Phase 2 PSL201 has just kick-started and recruitment is underway in two of the seven locations within the country where the project is going to take place. Around 80 subjects are expected to be part of the experiment. The work on the other sites will commence in the first half of 2020.

Usona remains hopeful because they noted that one in three drugs given breakthrough designations had received approval. They also are confident of moving into Phase 3 of the trial that has recently started. In 2018, Compass Pathways was given the breakthrough therapy status for clinical trials on psilocybin and the project is ongoing.

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials. What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” Charles Raison, Director of Clinical and Translational Research at Usona, said.

“Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”

The designation is an acknowledgement of the potenital of psilocybin, a common psychedelic drug, according to Substance Abuse and Mental Health Services Administration. It is classified under Schedule I, indicating the substance can become addictive and hence cannot be used for medical purposes.

Since psilocybin was shown to help deal with depression, anxiety and substance abuse, researchers from Johns Hopkins University had requested the government to move it to Schedule IV. So far, Oakland and Denver have decriminalized the chemical compound in 2019.

Psilocybin could potentially alter the subconsciousness and provide long-term relief to people suffering with incurable depressive symptoms. The FDA remains open to recommending tried-and-tested novel therapies of all kinds. Earlier this year on March 5, Esketamine nasal spray, another psychedelic drug, was approved by the FDA to be used along with an oral antidepressant in a clinical setting.

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