A promising new treatment for postpartum depression (PPD) could mark a major step forward in women's health care, researchers say.
Brexanolone injection works differently than existing antidepressant medications, and if approved by the US Food and Drug Administration later this year, will be the first new class of antidepressants in decades, and the first drug specifically indicated for PPD.
"With current antidepressant SSRIs (selective serotonin reuptake inhibitors) it could take four to six weeks to get a treatment response. In the brexanolone trials, we saw patients starting to feel better within days," says Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina School of Medicine and the trial's academic principal investigator.
Time is essential
Time is especially crucial for new mothers experiencing postpartum depression because the weeks and months following birth are a critical period for mother-infant bonding, says coauthor David Rubinow, chair of the psychiatry department.
Common symptoms of PPD—a mood disorder in women that fluctuations in reproductive hormones can trigger—include low mood, feeling overwhelmed, anxious and ruminating thoughts, potential withdrawal from the baby and her family, and suicidal thoughts in the most severe cases.
PPD is one of the most common complications of pregnancy, with between 10 and 20 percent of mothers worldwide experiencing it.
"Having a drug developed specifically for postpartum depression is a game-changer for women's health," says Meltzer-Brody.
"With our latest results, we believe that brexanolone, if approved, could provide relief for women with a range of postpartum severity."
As soon as 24 hours
The paper, published in The Lancet, includes a new integrated analysis of results from three double-blind, placebo-controlled trials that took place at 30 sites in the United States.
Eligible women were aged 18-45 years old and were six months postpartum or less at screening. They also had to be experiencing moderate to severe postpartum depression, which was assessed by the Hamilton Depression Rating Scale (HAM-D).
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 or a placebo.
102 women with moderate or severe PPD received brexanolone injection. These women also received evaluation throughout the infusion, after the infusion stopped, and then periodically for up to 30 days.
Another 107 women received a placebo and evaluation during the same timeframe.
Researchers observed the first statistically significant reduction in depression severity with brexanolone injection relative to placebo 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 was 17.0 points for women in the brexanolone injection group, versus 12.8 in the placebo group.
The reduction of symptoms in the patients receiving brexanolone injection maintained throughout the last study visit at Day 30. The most common adverse events following during brexanolone injection administration were headache, dizziness, and somnolence.
"This is a very different model for how we treat depression. Having a drug approved to treat PPD that works quickly and effectively, yet is also durable, would be a huge step forward for psychiatry in general," Meltzer-Brody says.
Brexanolone injection is an allosteric modulator of both synaptic and extra-synaptic GABAᴀ receptors. In postpartum depression, the GABA pathway may play a key role in regulating hormones that researchers believe can lead to PPD.
Sage Therapeutics is the developer of brexanolone injection and sponsor of the trials.
A new drug application is currently under review by the FDA and brexanolone injection has been granted Breakthrough Therapy Designation.
The FDA has assigned a Prescription Drug User Fee Act target date of December 19, 2018.
Source: UNC-Chapel Hill