The first oral drug suggested to treat postpartum depression (PPD) in adults, Zurzuvae (zuranolone), has received approval from the U.S. Food and Drug Administration. PPD is a significant depressive episode that can start later in pregnancy but usually starts after delivery. Until recently, the only form of therapy for PPD was an IV injection delivered by a medical professional at certain medical facilities.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.” – FDA mentioned.
Similar to other types of depression, PPD is characterised by sorrow and/or lack of interest in previously enjoyed activities as well as a lowered capacity for enjoyment. Cognitive impairment, feelings of despair or inadequacy, fatigue, or suicidal thoughts are just a few of the signs that it may show.
Two randomised, double-blind, placebo-controlled, multicenter trials showed that Zurzuvae is effective in treating PPD in adults. Women with PPD who matched the DSM-IV criteria for a severe depressive episode and whose symptoms started in the third trimester or within four weeks after delivery made up the trial’s subjects.
Patients in Study 1 were given a 50 mg dose of Zurzuvae or a placebo once a day in the evening for 14 days. In Study 2, patients were given a different zuranolone product for 14 days that was roughly equivalent to 40 mg of Zurzuvae or a placebo. Following the 14-day therapy, patients in both studies were observed for at least four weeks. The change in depression symptoms was the main outcome measure in both trials.
Zurzuvae can impair a person’s ability to drive and engage in other potentially dangerous activities, according to a boxed warning on the labelling. Patients can also be unable to gauge the extent of their disability. Patients should wait at least 12 hours after taking Zurzuvae before using heavy machinery or operating a vehicle to avoid the risk of injury.
Image source: www.fda.gov
Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. M.Sc. Biotechnology from the University of Kerala. Attended certificate course in Artificial Intelligence for Everyone from Deeplearning.AI, Influenza Prevention and Control from World Health Organization. Attended workshops related to Bioinformatics at the University of Kerala. 3 years of experience in website management. Experience in WordPress, Blogger, Google Analytics, and Google Search Console.
