As of March 2019, brexanolone - developed and made available commercially by Sage Therapeutics Inc. as the brand name product Zulresso - is the first drug to have ever been approved by the US FDA specifically for the treatment of postpartum depression (PPD) in adult females . Since PPD, like various other types of depression, is characterized by feelings of sadness, worthlessness or guilt, cognitive impairment, and/or possibly suicidal ideation, it is considered a life-threatening condition . Studies have consequently found that PPD can genuinely have profound negative effects on the maternal-infant bond and later infant development . The development and availability of brexanolone for the treatment of PPD in adult females subsequently provides a new and promising therapy where few existed before .
In particular, the use of brexanolone in treating PPD is surrounded with promise because it acts in part as a synthetic supplement for possible deficiencies in endogenous brexanolone (allopregnanolone) in postpartum women susceptible to PPD whereas many commonly used anti-depressive medications elicit actions that may modulate the presence and activity of substances like serotonin, norepinephrine, and/or monoamine oxidase but do not mediate activities directly associated with PPD like natural fluctuations in the levels of endogenous neuroactive steroids like allopregnanolone .
And finally, although brexanolone may also be undergoing clinical trials to investigate its abilities to treat super-refractory status epilepticus, it appears that some such studies have failed to meet primary endpoints that compare success in the weaning of third-line agents and resolution of potentially life-threatening status epilepticus with brexanolone vs. placebo when added to standard-of-care .
Brexanolone is a synthetic neuroactive steroid gamma-aminobutyric acid A (GABA(a)) receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adult women .
The University of Arizona Clinical & Translational Science Research Center, Tucson, Arizona, United States
Sage Investigational Site, Iowa City, Iowa, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
UNC Hospitals, Chapel Hill, North Carolina, United States
Yale School of Medicine, New Haven, Connecticut, United States
Perseverance Research Center, Scottsdale, Arizona, United States
ATP Clinical Research, Costa Mesa, California, United States
Wake Research, Los Alamitos, California, United States
Sage Investigational Site, Seattle, Washington, United States
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.