FDA approves Sage's Zulresso injection storapy for postpartum depression

PPD is a clear and easily identifiable form of severe depression, a common birth complication that affects some pregnant women and usually occurs late in pregnancy or within 4 weeks of childbirthrecently, Sage Therapeutics(http:// announcedthat the u.SFood andMedicines(http://Administration (
)FDA(http:// has approved the use of the Zulresso injection to treat postpartum depression (PPD)Sage expects Zulresso to be available in the U.Sby the end of JuneZulresso was approved through the FDA's priority review processPreviously, the FDA has granted Zulresso breakthrough drug eligibility (BTD) for the treatment of PPD, and in the European Union, the EMA has also granted priority drug eligibility (PRIME)Zulresso's active pharmaceutical ingredient is brexanolone, a deconcitrusion regulator that acts on both synaptic and synaptic GABAA receptorsThe variable regulation of neurotransmitter receptor activity can produce various degrees of desired activity, rather than full activation or total inhibitionZulresso's approval is based on data from three multicenter, randomized, double-blind, parallel group, placebo-controlled clinical studiesThese studies assessed the efficacy and safety of moderate to severe PPD in Zulresso injection therapyThe patients in the study group were maternal patients aged 18-45 who developed severe depressive symptoms no earlier than the end of pregnancy and no later than the fourth week after delivery, and were enrolled in the study six months before deliveryZulresso reached its primary endpoint at all dose levels in the three studies: in the 60th hour of treatment, the total score of Hamilton's depression score (HAM-D), a common measure of the severity of depression, was significantly lower than baseline in the 60th hour of treatment compared to the placebo groupearly in the 24th hour, the depressive symptoms in the Zulresso treatment group were relieved, and zulresso remained in good shape for 30 days of follow-upThe most common adverse events instudies were drowsiness, dry mouth, loss of consciousness, and redness