Rolling submission for SAGE 217 in major depressive disorder (MDD) and postpartum depression completed.- Sage Therapeutics and Biogen
Sage Therapeutics and Biogen announced the completion of the rolling submission of a New Drug Application (NDA) to the FDA for SAGE 217 (zuranolone) in the treatment of major depressive disorder (MDD) and postpartum depression (PPD)
Zuranolone is an investigational drug being evaluated as a rapid-acting, once-daily, 14-day oral short course treatment in adults with MDD and PPD. The submission completes the NDA filing that was initiated earlier this year.
The NDA submission includes data from the LANDSCAPE and NEST development programs for zuranolone. The LANDSCAPE program includes five studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL Studies). The NEST program includes two studies of zuranolone in adult women with PPD (ROBIN and SKYLARK Studies).
In the clinical development program to date, zuranolone showed rapid and sustained improvement of depressive symptoms with a generally well-tolerated and consistent safety profile. Zuranolone, a neuroactive steroid, has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. In people with depression, it may help to rapidly rebalance dysregulated neuronal networks to help restore brain function. Zuranolone targets brain networks responsible for functions such as mood, arousal, behavior, and cognition.
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