Sage Therapeutics seeks US approval of SAGE-547 for postpartum depression

Sage Therapeutics on Monday announced that it submitted an application to the FDA seeking approval of SAGE-547, an intravenous formulation of brexanolone, for the treatment of postpartum depression. The allosteric modulator of both synaptic and extra-synaptic GABA-A receptors was granted breakthrough therapy status by the agency in 2016.  

Sage noted that the filing for SAGE-547 was supported by safety and efficacy data from the Hummingbird Programme consisting of three clinical trials dubbed Study 202A, Study 202B and Study 202C. Last November, the drugmaker unveiled data illustrating that Study 202B and Study 202C, which included patients with moderate-to-severe postpartum depression, met their main goals.

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Additionally, Sage is developing the investigational GABA modulator SAGE-217 for the treatment of postpartum depression, with results from a Phase II trial expected later this year. Mid-stage study data released last December illustrated that the therapy was associated with significant improvements versus placebo in patients with moderate-to-severe major depressive disorder, while other results suggest the drug may have potential in treating sleep disorders.

For related analysis, see ViewPoints: Sage's GABA exploration journey continues bearing fruit.

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