FDA accepts new drug listing for brexanolone (SAGE-547) intravenous injection syltorapy for postpartum depression

recently, Sage Therapeutics announced thatFDA(which has accepted theofnew drugs (NDA) for the treatment of postpartum depression with brexanolone (SAGE-547) intravenous injections, and granted priority review eligibility, with pDUFA scheduled for approval on December 19, 2018about brexanolonebrexanolone is a different-form regulator of a type A receptor (GABAA receptor) that simultaneously regulates the function of GABAA receptors located in both synapses and synapses, restoring the balance between GABAA receptor and NMDA receptor (N-methyl-D-tenorine receptor) activity in the brain, with the potential to treat depressionrelated research
Sage Therapeutics filed for listing based primarily on data from two randomized, double-blind, parallel groupings, placebo-controlled Phase III studies (Study 202B and Study 202C) conducted in the United States in the Hummingbird projectthe two studies assessed the efficacy and safety of brexanolone in women aged 18 to 45 years with severe postpartum depressionThe patient was less than 6 months away from delivery at the time of entry, and depression occurred no earlier than the third pregnancy and no later than 1 month after deliveryresults showed that all doses of brexanolone in both studies had a more significant reduction in the baseline compared to the baseline after 60h injection, with good tolerance and similar adverse event incidence ratesbrexanolone intravenous fluids have been identified by the FDA's breakthroughdrug(eligibility and EMA) for postpartum depression, an indication of postpartum depressionIf approved, brexanolone would be the first drug to treat postpartum depression and the firstproduct to be commercialized by Sage Therapeutics