Receiving an IV dose of brexanolone for 60 hours significantly improved depression among women with severe postpartum depression, compared with placebo, according to phase 2 findings.
“There is a significant unmet need for new treatment options in [postpartum depression], for mothers suffering from the disorder, as well as their children and families. Currently available pharmacologic treatment options for [postpartum depression] do not target the underlying mechanism or biology,” study researcher Samantha Meltzer-Brody, MD, MPH, of University of North Carolina Center for Women’s Mood Disorders, said in a press release. “The rapid onset of action and duration of effect observed in this study compared to placebo suggest that brexanolone has the potential to address unmet needs in the treatment of patients suffering from [postpartum depression]. If successfully developed and approved, this would be an enormous step forward for the field.”
To assess efficacy of brexanolone, an IV formulation of allopregnanolone, for treatment of postpartum depression, researchers conducted a phase 2 randomized, double-blind, placebo-controlled trial among women receiving inpatient treatment for severe postpartum depression. Study participants were randomly assigned to receive a single, continuous IV dose of brexanolone (n = 10) or placebo (n = 11) for 60 hours.
From baseline to 60 hours, mean reduction in Hamilton Rating Scale for Depression (HAM-D) total scores was 21 points among participants who received brexanolone, compared with 8.8 points among those who received placebo (P = .0075).
There were no deaths, serious adverse events, or discontinuations due to adverse events reported in either treatment group.
Adverse events occurred in four participants who received brexanolone and eight who received placebo.
Dizziness and somnolence were the most commonly reported adverse events among the brexanolone group.
Two participants who received brexanolone reported moderate treatment-emergent adverse events, sinus tachycardia and somnolence.
“Postpartum depression is a common, biological complication of childbirth. It is a serious mood disorder associated with a range of debilitating symptoms that impact a women’s ability to function, and is a leading cause of maternal suicide,” Steve Kanes, MD, PhD, chief medical officer of Sage, said in the release. “The publication of these data in The Lancet highlights the potential for brexanolone to be a treatment option for [postpartum depression]. We are hopeful these findings will aid in the understanding of this disorder and the development of effective therapies.” – by Amanda Oldt
Disclosure: Kanes is an employee of Sage Therapeutics, Inc, with stock or stock options and has a patent pending for SAGE-547 for neuropsychiatric conditions. Please see the study for a full list of relevant financial disclosures.