Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application for Zuranolone to the FDA in 2022
The FDA will review zuranolone for the treatment of depression in the first half of 2022.
The FDA will review zuranolone for the treatment of depression in the first half of 2022.
This review discusses the novel neurosteroid antidepressant brexanolone for the treatment of postpartum depression.
Zuranolone has antidepressant effects in women with severe PPD, observed as early as 3 days after initiation of treatment. Â
Women may experience depression and post-traumatic symptoms, especially those who were separated from their newborns after delivery and those with severe COVID-19 illness during pregnancy or after delivery.Â
Postpartum depression (PPD) is a relatively common problem, affecting between 10% and 15% of women after delivery. Although it is difficult to reliably predict which women in the general population will experience postpartum depression, it [...]
In a given year, about 10% of mothers in the United States experience a major depressive episode (MDE). Roughly translated, this means about 1 in 10 children is exposed to maternal depression each year (Ertel [...]
In 2019, brexanolone was introduced by Sage Therapeutics as Zulresso, a novel treatment for postpartum depression. The oral version of this novel antidepressant – SAGE 217 or zuranolone – is now finishing up its Phase [...]
About 15% of women will experience postpartum depression after the birth of a child. While most of those women will have unipolar depression, a certain number of women will have bipolar depression. At this juncture, [...]
Post-traumatic stress disorder (PTSD) is common among women of child-bearing age. While we are increasingly attentive to screening for depressive symptoms during pregnancy and after delivery, less often do we inquire about PTSD symptoms. [...]
The US Preventive Services Task Force (USPSTF) issued recommendations that all pregnant and postpartum women should be evaluated in order to determine risk for depressive illness and recommends that women at increased risk for [...]