Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S....
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news

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This study was conducted on 120 women (60 with postpartum depression and 60 without) in Izeh, Iran. A socio-demographic questionnaire and Beck Depression Scale were used for data collection. The ELISA method was used for measuring 25-OH vitamin D (ng). The participants were classified according to their vitamin D level as follows: 25-OH-D 30ng/ml as normal. Data were analyzed using the independent t-test or Mann-Whitney test, chi-square and logistic regression test. The mean level of vitamin D of women with postpartum depression was lower than that in normal women (16.89±7.05 vs. 21.28±7.13, p=0.001). More th...
Source: Journal of Medicine and Life - Category: General Medicine Tags: J Med Life Source Type: research
Yesterday the U.S. Food and Drug Administration (FDA)approved Zulresso (brexanolone) for the treatment of postpartum depression (PPD). It is the first drug approved by the FDA specifically for PPD. PPD is believed to be caused by the rapid change in hormones immediately after giving birth and is estimated to affect 400,000 women annually.“Postpartum depression is a serious condition that, when severe, can be life threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” said Tiffany Farchione, M.D., a...
Source: Psychiatr News - Category: Psychiatry Tags: brexanolone FDA approval GABA neurotransmitter postpartum depression Zulresso Source Type: research
Zulresso administered by IV infusion over 60 - hour period; patients must be monitored during infusion
Source: The Doctors Lounge - Psychiatry - Category: Psychiatry Tags: Family Medicine, Gynecology, Pharmacy, Psychiatry, Institutional, Source Type: news
First postpartum depression therapy, an IV drug, approved by U.S. Food and Drug Administration.
Source: CBC | Health - Category: Consumer Health News Tags: News/Health Source Type: news
In this message, Dr. Gordon discusses the role of NIMH and others in the bench-to-bedside story of bexanolone, which has just been approved by the FDA as the first treatment specifically for postpartum depression.
Source: NIMH Directors Blog - Category: Psychiatry Authors: Source Type: blogs
In this message, Dr. Gordon discusses the role of NIMH and others in the bench-to-bedside story of bexanolone, which has just been approved by the FDA as the first treatment specifically for postpartum depression.
Source: National Institute of Mental Health - Category: Psychiatry Authors: Source Type: news
FDA approval of the postpartum depression treatment brexanolone represents the final phase of a bench-to-bedside journey for this drug — a journey that began in the NIMH Intramural Research Program. NIMH experts are available to provide information on postpartum depression and the importance of, and the science underlying, this new drug.
Source: National Institute of Mental Health - Category: Psychiatry Authors: Source Type: news
The FDA has approved biopharma Sage Therapeutics' first product, a drug that the company says will be the first product specifically designed to treat postpartum depression. Zulresso is Sage's (Nasdaq: SAGE) first product to reach the market and one of two treatments the company has developed to treat postpartum depression. Its second potential therapy, an oral medication known as SAGE 217, succeeded in a late-stage trial as a postpartum treatment and is also being ev aluated as a potential major…
Source: bizjournals.com Health Care:Physician Practices headlines - Category: American Health Authors: Source Type: news
(MedPage Today) -- " Important new treatment option " for women suffering from post-partum depression, agency says
Source: MedPage Today Psychiatry - Category: Psychiatry Source Type: news
Approximately 1 in 9 women in the United States experiences symptoms.
Source: National Institutes of Health (NIH) News Releases - Category: American Health Source Type: news
More News: Depression | Drugs & Pharmacology | New Drug Applications | Postnatal Depression