Major Depressive Disorder Steroid Treatment Gets FDA Fast Track Designation

Avatar photoLea Eslava-Kim, PharmD
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FDA Announces Draft Guidance for Developing Drugs to Combat Alcoholism
FDA Announces Draft Guidance for Developing Drugs to Combat Alcoholism
Major depressive disorder could find a potential new treatment in SAGE-217, which received FDA fast track designation.

The Food and Drug Administration (FDA) has granted Fast Track designation to SAGE-217 (Sage Therapeutics) for the potential treatment of major depressive disorder (MDD).

SAGE-217 is a novel, orally-active, second-generation neuroactive steroid that acts as a positive allosteric modulator of synaptic and extrasynaptic GABAA receptor subtypes. Its unique pharmacokinetic profile and selective properties allow for once-daily oral dosing while minimizing potential off-target side-effects. 

Sage is currently investigating SAGE-217 in a Phase 2 clinical development program, including 4 studies in both mood and movement disorders.  

For more information visit Sagerx.com.

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Reference

Sage Therapeutics Receives Fast Track Designation for SAGE-217 for the Treatment of Major Depressive Disorder [news release]. Cambridge, Massachusetts: Suda Communications LLC;  May 18, 2017. http://www.businesswire.com/news/home/20170518005163/en/Sage-Therapeutics-Receives-Fast-Track-Designation-SAGE-217. Accessed  May 19, 2017.

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This article originally appeared on MPR