The first drug for women suffering postpartum depression received federal approval on Tuesday, a move likely to pave the way for a wave of treatments to address a debilitating condition that is the most common complication of pregnancy. The drug works very quickly, within 48 hours — a significant improvement over currently available antidepressants, which can take two to four weeks to have an effect, if they work at all. Experts say the new treatment will provide immediate relief for mothers whose depression keeps them from providing their babies with the care, bonding and nurturing that is crucial for healthy development. As many as one in seven American women experience depression during or after pregnancy. “Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.<doc-sep>For the first time in history, the US Food and Drug Administration has approved a drug specifically indicated for the treatment of postpartum depression, which experts say offers new hope to women and physicians. The FDA announced the approval of an intravenous infusion of the drug brexanolone, which will be sold as Zulresso. It has been shown in clinical trials to work within hours to treat the symptoms of postpartum depression, a serious mental illness that impacts 1 in 9 new mothers after childbirth. CNN's Dr. Sanjay Gupta reports.<doc-sep>Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina at Chapel Hill, who led the clinical trials for the drug, said the medication is such an improvement over current therapies that she doubts the IV administration will discourage its use. She noted that postpartum depression, one of the most common complications of childbirth, is “underdiagnosed and neglected,” and that suicide is a major cause of maternal death.<doc-sep>The first-ever drug created specifically to combat postpartum depression was approved by the U.S. Food and Drug Administration (FDA) on Tuesday. Zulresso, created by Sage Therapeutics, is an IV drug administered "as a continuous infusion" over the course of 60 hours, or two and a half days, the agency announced in a news release. WOMAN CLAIMS HOSPITAL STORED FROZEN EMBRYO FOR YEARS WITHOUT HER KNOWLEDGE In a company-funded study of new mothers with moderate or severe postpartum depression, reportedly half the women given Zulresso had depression end within two and a half days — about double the rate of those in a comparison group given dummy treatments. Getting the "baby blues" after childbirth is common, according to the Mayo Clinic. After childbirth, "most" new mothers experience a range of symptoms, including mood swings, crying, trouble sleeping and irritability. But some other mothers experience stronger, more severe emotions that are considered postpartum depression. Excessive crying, overwhelming fatigue, difficulty bonding with the newborn child, fear of being an inadequate mother or total hopelessness are symptoms connected to postpartum depression that medical officials say can develop within the first few weeks following childbirth, but can start earlier or later. It affects around 400,000 American women a year and can be treated with antidepressants, which can take six to eight weeks to work and don't help everyone, or with counseling. DEPRESSION AND SUICIDAL THOUGHTS HAVE DOUBLED IN YOUNG AMERICANS, STUDY SAYS "Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child," Dr. Tiffany Farchione, of the FDA's Division of Psychiatry Products, stated in the news release. Farchione added that, "Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option." Zulresso's active ingredient, brexanolone, mimics a derivative of the naturally occurring hormone progesterone, levels of which can plunge after childbirth. Sage Chief Executive Dr. Jeff Jnas says the infusion helps restore normal levels and emotions. CLICK HERE TO GET THE FOX NEWS APP Sage said Zulresso will cost $34,000 without insurance, plus costs for staying in a hospital or infusion center. Whether the treatment gets covered by insurance is determined by each insurance company, which also sets the out-of-pocket costs, depending on the plan. The company — which is developing a similar treatment in pill form — plans to begin selling the drug in late June. The Associated Press contributed to this report.<doc-sep>
The first drug specifically targeted at treating postpartum depression in new mothers has been approved, the Food and Drug Administration announced Tuesday. Brexanolone, sold as Zulresso, is delivered as a continuous intravenous infusion over the course of 60 hours, the FDA said. The New York Times reported the drug works quickly – within two days – and costs $20,000 or more. "Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child," said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. The Centers for Disease Control and Prevention estimated that postpartum depression affects one in nine women nationally. Postpartum depression is treated with counseling and medication that can take weeks to work, the National Institute of Mental Health said. Untreated postpartum depression can last for months or years, the institute said. Feb. 21:The realities of postpartum, as told by celebrity moms Beyonce, Chrissy Teigen and more June 2017:We all know about postpartum depression, but have you heard of postpartum anxiety? Zulresso will be available only from certified health care facilities through a restricted program called the "Zulresso REMS Program," the FDA said. Jeff Jonas, CEO of Sage Therapeutics, the company that developed Zulresso, told CNN the drug will be available in June. The FDA said it approved Zulresso after two clinical studies demonstrated the medicine outperformed a placebo at improving symptoms of depression over 30 days. Those studies were sponsored by Sage, which is working to offer a pill version of the treatment, The Times reported.