New drug application is under review by FDA
New drug application is under review by FDA
MANHASSET, N.Y., Aug. 31, 2018 /PRNewswire/ -- An integrated analysis of one phase 2 and two phase 3 clinical trials published today in The Lancet found that the investigational medication, brexanolone injection 90 µg/kg/h (formerly SAGE-547 injection), demonstrated a reduction in depressive symptoms in women suffering from moderate and severe postpartum depression (PPD) compared to placebo by the end of the primary timepoint of 60-hours. The publication was based on the work of a group of investigators that included researchers from The Feinstein Institute for Medical Research and was sponsored by Sage Therapeutics. Based on these and earlier positive findings, Sage Therapeutics applied for U.S. Food and Drug Administration (FDA) approval of brexanolone injection, and if approved, it will be the first medication specifically for the treatment of PPD.
Up to 20 percent of all women giving birth globally will develop PPD, with 40 to 80 percent experiencing moderate to severe PPD. The mood disorder can develop during pregnancy and up to four weeks after giving birth. Women with PPD can experience a variety of symptoms, including depressed mood, feelings of being overwhelmed with anxiety, guilty thoughts, poor concentration and sleep, difficulty bonding with their child, withdrawal from family and friends, thoughts of suicide and fear of not being a good mother. These symptoms experienced by the mother can also have an impact on her child as well, potentially affecting the child’s temperament, cognitive and social development.
“PPD is often treated with antidepressants that are approved for the treatment of depression not linked to childbirth. It can take several weeks for women to feel better once a traditional antidepressant is started, with many women not achieving adequate symptom relief,” said Kristina M. Deligiannidis, MD, an author on the study who is an associate professor at the Feinstein Institute for Medical Research and Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, and director of Women’s Behavioral Health at Zucker Hillside Hospital. “There is a need for specialized PPD treatment. The findings of our new analysis are promising -and we hope our work will lead to a new treatment option for moderate to severe PPD.”
The integrated analysis looked at results of the trials which randomized 209 women to receive a double-blinded 60-hour infusion of either brexanolone injection 90 µg/kg/hr or placebo. A unique dose group of brexanolone 60 µg/kg/hr in one of the studies was not included in the integrated analysis. Brexanolone injection was administered to 102 women with moderate or severe PPD who also were evaluated throughout the infusion, after the infusion stopped and then periodically for up to 30 days. Another 107 women were administered a placebo and evaluated during the same timeframe. The first statistically significant reduction in depression severity with brexanolone injection relative to placebo was observed as early as 24 hours after dosing. At the end of the 60-hour infusion, the average reduction in patients’ Hamilton Rating Scale for Depression (HAM-D or depression severity score) was 17.0 points for women in the brexanolone injection 90 µg/kg/hr group, versus 12.8 in the placebo group (p<0.0001). The reduction of symptoms in the patients receiving brexanolone injection was maintained throughout the last study visit at Day 30. The most common (≥10% of subjects) adverse events following during brexanolone IV administration were headache, dizziness, and somnolence.
“Dr. Deligiannidis and her team are leaders in PPD research,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institute. “Their pioneering efforts are producing knowledge of a new possible therapy that should give hope for alleviating the suffering of PPD in many childbearing women.”
About the Feinstein Institute
The Feinstein Institute for Medical Research is the research arm of Northwell Health, the largest healthcare provider in New York. Home to 50 research laboratories and to clinical research throughout dozens of hospitals and outpatient facilities, the Feinstein Institute includes 4,000 researchers and staff who are making breakthroughs in molecular medicine, genetics, oncology, brain research, mental health, autoimmunity, and bioelectronic medicine - a new field of science that has the potential to revolutionize medicine. For more information about how we empower imagination and pioneer discovery, visit FeinsteinInstitute.org.
Contact: Heather E. Ball Mayer
516-465-7917
hball@northwell.edu
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SOURCE The Feinstein Institute for Medical Research
