Policy & Regulation
Usona Institute's Psilocybin granted US FDA grants Breakthrough Therapy Designation
26 November 2019 -

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to United States-based Usona Institute's psilocybin intended for the treatment of major depressive disorder (MDD), it was reported yesterday.

Breakthrough Therapy Designation establishes the FDA's organisational commitment to promoting an efficient development program for psilocybin in MDD.

The new status follows the recent introduction of Usona's Phase two clinical trial, PSIL201, which included around 80 participants at seven study sites around the US. Two of the seven study sites are presently hiring, with the others expected to be active by the first quarter of 2020.

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