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Getty Images\/FatCamera<\/p>\n <\/span> \nThe Food and Drug Administration (FDA) just approved a novel medication to treat postpartum depression (PPD).<\/span>\n<\/p>\n \nThe drug, zuranolone, designed by the pharmaceutical companies Biogen Inc. and Sage Therapeutics, Inc., is a completely new approach to treating both PPD and major depressive disorder (MDD), offering hope during a critical period of time for mother and baby.<\/span>\n<\/p>\n \n\u201cMental health issues are one of the most common complications in pregnancy and postpartum,\u201d Christopher Zahn, MD chief of Clinical Practice and Health Equity and Quality at the American College of Obstetrics and Gynecology (ACOG), told Health<\/em>.\n<\/p>\n \nPPD affects half a million people in the United States every year, according to data published in 2020.<\/span>\n<\/p>\n \n\u201cIt is encouraging that postpartum individuals may now have more options to manage what can be a debilitating condition,\u201d Zahn said.\n<\/p>\n <\/span> <\/p>\n \nWhile current antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) target the brain\u2019s serotonin receptors, zuranolone is designed to bind to GABA receptors, the main neurotransmitter in the nervous system.\n<\/p>\n \n\u201cIt’s a major driver in the brain,\u201d said Laura Gault, MD, PhD, chief medical officer of Sage Therapeutics, Inc. \u201cWe think of depression as the disruption of brain function\u2014disconnections in the brain that are driven by GABA disruption.\u201d\n<\/p>\n \nZuranolone works by restoring the connections between GABA receptors that depression disrupts, which, Gault said, restores normal brain function.\n<\/p>\n \nThe concept isn\u2019t novel, but the way the drug is administered and how long it lasts is a huge step forward. The FDA approved Zulresso (brexanolone) injection in 2019, which also acts on the GABA receptors but presents a host of access issues.<\/span> The injection is administered over 60 hours, or about 2.5 days, and must be done in a monitored setting, such as a hospital.\n<\/p>\n \n\u201cIt limited the access to that medication for a lot of people who otherwise would have qualified for it. An oral form that has the same efficacy would be huge,\u201d Elizabeth M. Fitelson, MD, director of the Women’s Program at the Columbia University Department of Psychiatry, told Health<\/em>.\n<\/p>\n What Is the Treatment for Depression?<\/span><\/p>\n <\/span> <\/p>\n \nIn total, studies on zuranolone have included 3,500 patients.<\/span> A Phase 3 clinical trial for zuranolone included 200 people who had recently given birth. Half were given a placebo and half took a pill that contained 50mg of zuranolone every day for 14 days.\n<\/p>\n \nThe researchers found that not only did those who took the novel antidepressant report fewer depressive symptoms, but the medication appeared to be both fast-acting and long-lasting, something that also set it apart from existing antidepressants.\n<\/p>\n \nGault said that during the trial, the first check-in was three days after participants took the first dose, and already, they saw improvements. The effects appeared to magnify over the 14 days in which the medication was administered and the effects lasted an average of 249 days.\n<\/p>\n \nZuranalone can be administered in pill form because it has a much longer half-life than Zulresso. It\u2019s also the reason the drug\u2019s effects can last so long. Most people in the trial\u201480%\u2014needed just one or two courses to get them through their PPD.\n<\/p>\n \n\u201cThey either needed 14 or 28 days of treatment in a whole year. It\u2019s a paradigm shift in how we think about treating depression,\u201d Gault said.\n<\/p>\n \nAlthough they can be used during the postpartum period, it\u2019s common for SSRIs and SNRIs to take weeks or months to become effective, which cuts into a critical time for bonding.\n<\/p>\n \n\u201cIt\u2019s such a meaningful time in a family\u2019s life,\u201d Fitelson said. \u201cThe baby needs to form attachment bonds and if a parent is anxious or depressed, that can be delayed. Rapid improvement is actually very significant because timing does matter.\u201d\n<\/p>\n <\/span> <\/p>\n \nAccording to Fitelson, both zuranolone and the IV-administered Zulresso are significant products of improvements in research on the female reproductive life cycle and an effort to understand why women are twice as likely as men to have a depressive episode in their lifetime.\n<\/p>\n \n\u201cFor so long, even in animal studies, females were left out of psychological research," Fitelson said. "Our biases about gender have blocked novel pathways and there has been a dearth of truly novel treatments because of that."\n<\/p>\n \nResearchers have traditionally shied away from using females, even in rodent studies, because of natural hormonal shifts that were thought to interfere with data.<\/span> But understanding these hormonal shifts is key to creating novel treatments, especially for the period during and after pregnancy.\n<\/p>\n \nACOG defines PPD as depression that onsets within the first year of giving birth.<\/span> While the symptoms of PPD and MDD are generally the same, the triggers are thought to be different. A key risk factor is sensitivity to the radical hormonal shifts that happen during delivery.\u00a0\n<\/p>\n \nAccording to Fitelson, the placenta pumps out huge amounts of hormones, including estrogen, throughout pregnancy.\n<\/p>\n \n\u201cWhen the placenta is delivered, those plummet to essentially none. It\u2019s a 20-fold higher change than hormone shifts that occur during the menstrual cycle. For some, that\u2019s a trigger for PDD,\u201d she said.\n<\/p>\n \nThere are also factors including complications that can happen during pregnancy and delivery and the flood of stress hormones that are released during labor.\n<\/p>\n \n\u201cThen you have this baby to take care of, you\u2019re sleep deprived and isolated from your normal life. It\u2019s not just one factor that is the answer for why people seem to be at higher risk for depression and anxiety during this time,\u201d Fitelson said.\n<\/p>\n When To Switch or Adjust Your Antidepressant for Better Results<\/span><\/p>\n <\/span> <\/p>\n \nWhile the FDA has announced its approval of zuranolone, Gault said additional paperwork is required before a new drug hits the market. Gault guesses zuranolone will be available to the public sometime in November.\n<\/p>\n \nLike all drugs, zuranolone can produce side effects, though the majority were mild or moderate in severity. Trials showed that zuranolone caused somnolence (excessive sleepiness) in about 15% of people and headache in about 11%. Nearly 14% of people who took the novel antidepressant experienced dizziness.\n<\/p>\n \nFitelson noted patients should not see zuranolone as the only depression treatment for PPD if it isn\u2019t accessible or agreeable with them. \u201cI don\u2019t want people to think it\u2019s the only medication and that if they don\u2019t get it, they won\u2019t get better,\u201d she said. \u201cThere are many ways to get better, including therapy.\u201d\n<\/p>\n \nUltimately, the drug is an important step for postpartum mental health care. \u201cTo be able to take a once-a-day medication at home,\u201d Fitelson said, \u201cand not interrupt time with the child, to have your usual supports at home, and to increase access, is really exciting.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":" The FDA just approved zuranolone, a new medication to treat postpartum depression. The drug is in pill form and meant to be taken once a day for 14 days for fast-acting treatment. Postpartum depression impacts half a million people in the United States every year; this new drug is an exciting opportunity in patient care. 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\n<\/figcaption><\/figure>\n A Novel Approach to Depression Treatment <\/span> <\/h2>\n
A Fast- and Long-Acting Treatment <\/span> <\/h2>\n
A Huge Step in Postpartum Medicine <\/span> <\/h2>\n
Treatment Could Be Available to Patients in Late 2023 <\/span> <\/h2>\n