Neuroactive Steroid Gets Fast Tracked for Major Depressive Disorder
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 four studies in both mood and movement disorders.
For more information visit Sagerx.com.