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FDA designates psychedelic psilocybin a ‘Breakthrough Therapy’ for major depression

The US Food and Drug Administration (FDA) has designated psilocybin therapy as a Breakthrough Therapy for major depressive disorder, paving the way for further research on the hallucinogenic substance.

The Breakthrough Therapy designation is a process designed to speed up the development and review of drugs intended to treat a serious condition, according to the FDA. The designation is typically requested by drug companies and is granted when preliminary clinical evidence suggests that a drug may demonstrate substantial improvements over available therapy.

Usona Institute received the designation for psilocybin use in the treatment of major depressive disorder (MDD), which is a mood disorder characterized by a persistent feeling of sadness and loss of interest.

“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,” said Charles Raison, MD, Director of Clinical and Translational Research at Usona. “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.”

Late last year, the FDA granted the designation to the work being done by COMPASS Pathways. The company is continuing to investigate psilocybin as a therapy for treatment-resistant depression.

Psilocybin is the naturally-occurring psychoactive component found in hallucinogenic or “magic” mushrooms. When consumed, it can cause euphoria and sensory distortion. It is considered non-addictive.

Earlier this year, Denver became the first city in the US to decriminalize hallucinogenic mushrooms.


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