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FDA Grants Approval for First Medication to Treat Postpartum Depression

Federal health officials have given the green light to the first medication specifically designed to treat severe postpartum depression. Postpartum depression affects thousands of new mothers in the U.S. each year, and while it often resolves on its own within a few weeks, it can persist for much longer. The newly approved medication, called Zurzuvae, is taken once daily for a period of 14 days.

Dr. Tiffany Farchione, FDA’s director of psychiatric drugs, stated that having an oral medication as an option will greatly benefit women coping with extreme feelings of depression after childbirth. Standard treatment for postpartum depression currently involves counseling and antidepressants, which can take several weeks to show results and don’t work for everyone.

Zurzuvae is manufactured by Sage Therapeutics and is related to an infused drug that is administered intravenously over three days in a medical facility. Although the intravenous drug was approved by the FDA in 2019, it is not widely used due to its high cost and logistical challenges.

The FDA’s approval of Zurzuvae is based on two studies conducted by the company, which demonstrated that women who took the medication experienced fewer signs of depression compared to those who were given a placebo. The benefits, as measured by a psychiatric test, were evident in as little as three days for many patients.

Sahar McMahon, a participant in one of the studies, reported significant improvements in her mood and outlook within days of taking Zurzuvae. The medication allowed her to feel like herself again and restored her desire to interact with her children.

Dr. Kimberly Yonkers from Yale University believes that Zurzuvae will likely be prescribed for women who haven’t responded to traditional antidepressants, as its effects are quite strong. However, she also emphasized the importance of obtaining more data on how women fare after an extended period of time.

The pricing of Zurzuvae has not yet been disclosed by Sage Therapeutics, but it will likely play a crucial role in determining its accessibility and usage. The side effects of the medication are milder than those of the intravenous version and include drowsiness and dizziness.

Zurzuvae and the intravenous form both mimic a derivative of progesterone, a female hormone that is essential for maintaining a pregnancy. Levels of progesterone can drop significantly after childbirth, contributing to the development of postpartum depression.

Sage Therapeutics’ medications belong to a new class known as neurosteroids, which stimulate a different brain pathway compared to older antidepressants that target serotonin.

In conclusion, the FDA’s approval of Zurzuvae provides hope for mothers suffering from severe postpartum depression by offering a new treatment option that has shown promising results in clinical studies.

Unique perspective: Postpartum depression can have a debilitating impact on new mothers, affecting not only their mental well-being but also their ability to care for and bond with their newborns. By granting approval for Zurzuvae, the FDA is acknowledging the importance of addressing this condition and taking a step towards providing effective treatment options. This milestone highlights the ever-growing understanding of mental health and the recognition of the unique challenges faced by women during the postpartum period. It is a significant advancement in improving the overall well-being of both mothers and their children.

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