"UNC researchers say the results from the multisite phase  and  trials of brexanolone injection are not only promising but could change the way postpartum depression PPD is treated. Brexanolone injection works differently than existing antidepressant medications and if approved by the U.S. Food and Drug Administration FDA 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 said the trials academic principal investigator Samantha MeltzerBrody https MD MPH director of Perinatal Psychiatry Program at the UNC School of Medicine. David Rubinow MD chair of the Department of Psychiatry at the UNC School of Medicine and a coauthor of the paper says time is especially crucial for new mothers experiencing postpartum depression because the weeks and months following birth are a critical period for motherinfant bonding. Common symptoms of PPD  a mood disorder in women that can be triggered by fluctuations in reproductive hormones  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  and  percent of mothers worldwide experiencing it. Having a drug developed specifically for postpartum depression is a gamechanger for womens health said MeltzerBrody. With our latest results we believe that brexanolone if approved could provide relief for women with a range of postpartum severity. The paper published in The Lancet includes a new integrated analysis of results from three doubleblind placebocontrolled trials that took place at  sites in the U.S. including UNCs Perinatal Psychiatry Unit. Eligible women were aged  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 HAMD. The integrated analysis looked at results of the trials which randomized  women to receive a doubleblinded hour infusion of either brexanolone injection  gkghr or placebo. A unique dose group of brexanolone  gkghr in one of the studies was not included in the integrated efficacy analysis but was included in integrated analyses of safety. Brexanolone injection  gkghr was administered to  women with moderate or severe PPD who also were evaluated throughout the infusion after the infusion stopped and then periodically for up to  days. Another  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  hours after dosing. At the end of the hour infusion the average reduction in patients Hamilton Rating Scale for Depression HAMD or depression severity score was . points for women in the brexanolone injection  gkghr group versus . in the placebo group p.. The reduction of symptoms in the patients receiving brexanolone injection was maintained throughout the last study visit at Day . The most common  of subjects 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 MeltzerBrody said. Brexanolone injection is an allosteric modulator of both synaptic and extrasynaptic GABA 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  ."