Dr. Meltzer-Brody is the Ray M. Hayworth Distinguished Professor, Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, North Carolina. Dr. Deligiannidis is Associate Professor, Department of Psychiatry, Zucker Hillside Hospital and Feinstein Institute for Medical Research, Glen Oaks, New York. Dr. Colquhoun is VP Medical Science, Sage Therapeutics, Inc., Cambridge, Massachusetts. Dr. Kanes is Chief Medical Officer, Sage Therapeutics, Inc., Cambridge, Massachusetts.
Disclosures Dr. Meltzer-Brody receives personal fees from Medscape and received grants from Sage Therapeutics, Inc., awarded to the University of Carolina during the conduct of the brexanolone injection clinical trials, and grants from Janssen, Patient-Centered Outcomes Research Institute, and the National Institutes of Health (NIH) outside the submitted work. Dr. Deligiannidis serves as a consultant to Sage Therapeutics, Inc., receives National Institute of Mental Health support and royalties from an NIH employee invention, and received grants from Sage Therapeutics, Inc., awarded to the Zucker Hillside Hospital during the conduct of the brexanolone injection and SAGE-217 clinical trials. Dr. Colquhoun and Dr. Kanes are employees of Sage Therapeutics, Inc., with stock/stock options.
Concomitant medications. Caution patients that taking opioids or other CNS depressants, such as benzodiazepines, in combination with brexanolone may increase the severity of sedative effects.
Suicidal thoughts and behaviors.Advise patients and caregivers to look for the emergence of suicidal thoughts and behavior and instruct them to report such symptoms to their clinician. Consider changing the therapeutic regimen, including discontinuing brexanolone, in patients whose depression becomes worse or who experience emergent suicidal thoughts and behaviors.
Why Rx?
Postpartum depression is a common and often devastating medical complication of childbirth that can result in adverse outcomes for the patient, baby, and family when left undertreated or untreated. There is a great need to identify and treat women who develop PPD. Rapid and sustained resolution of symptoms in women who experience PPD should be the goal of treatment, and consequently, brexanolone injection presents an important new tool in available treatment options for PPD.
Bottom Line
Brexanolone injection is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive allosteric modulator that’s been FDA-approved for the treatment of postpartum depression (PPD). It is administered as a continuous IV infusion over 60 hours. The rapid and sustained improvement of PPD observed in clinical trials with brexanolone injection may support a new treatment paradigm for women with PPD.
