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FDA Approves 1st Eever postpartum depression Medication

There is new hope for women who suffer from postpartum depression, a type of depression that can occur in some women after giving birth to a child. The FDA has approved for the first time a medication for treating this illness. Zuranolone can now be used as a pill taken once a day in a 50 mg tablet.

Postpartum depression (PPD) is a common mood disorder that affects about 1 in 7 women after giving birth. It is characterized by a persistent feeling of sadness, hopelessness, and worthlessness that can interfere with a woman’s ability to care for herself and her baby.

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The exact cause of PPD is not fully understood, but it is thought to be caused by a combination of factors, including genetics, hormonal changes – the rapid drop in hormones after childbirth can trigger mood changes in some women – and personal history, such as with women who have experienced trauma or abuse in the past are more likely to develop PPD.

And postpartum depression comes with an even bigger stigma than depression in general. When women are diagnosed with PPD, they tend to feel like they are being told they are a bad mother, or that they are mentally ill. And ordinarily these women have not had previous mental health issues, including basic depression. So it is also hard sometimes to get affected women to deal with the problem.

And so far traditional anti-depressants, for whatever reason, have not been so effective in treating PPD.

As many as 15% of women who give birth in the U.S. are thought to suffer from postpartum depression. But it is not always recorded as such when a woman goes through PPD because she and her family may not even know it and people from low income communities are not as likely to have access to mental health services or information about such issues.

This is why doctors try to let people know about postpartum depression before childbirth so friends and family will be able to spot the systems should they occur and be prepared to try and deal with it.

In its decision to authorize the drug’s use, the DFA explained that the efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. The trial participants were women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery. In Study 1, patients received 50 mg of Zurzuvae or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product that was approximately equal to 40 mg of Zurzuvae or placebo, also for 14 days. Patients in both studies were monitored for at least four weeks after the 14-day treatment.

“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.”

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