Usona Institute's Psilocybin Receives the US FDA Breakthrough Therapy Designation for Major Depressive Disorder
Shots:
- The US FDA has granted the BT designation to psilocybin for promoting the efficient development of programs for psilocybin in MDD
- The BT designation follows the launch of Usona’s P-II PSIL201 which includes ~80 patients at 7sites across the US. 2/7 study sites are recruiting while others are expected to be active by Q1’20
- The BT designation to psilocybin targets the unmet medical need and the potential for improvement over existing therapies and foster Usona’s goal to advance the treatment paradigm toward new drug approval
Click here to read full press release/ article | Ref: Buisnesswire | Image: Businesswire
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