2023-08-07 08:55:00
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The United States Food and Drug Administration (FDA) has approved the drug zuranolone for the treatment of postpartum depression.
This approval marks an important milestone, as it is the first oral pill approved by the FDA in the United States specifically to treat postpartum depression, a serious mental illness that can develop in approximately 1 in 7 new mothers after childbirth.
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Postpartum depression is a complex and debilitating condition that can manifest itself through a variety of symptoms, including intense sadness, feelings of guilt and worthlessness, and in severe cases, thoughts of harming yourself or harming your child. The severity of these symptoms can have a profound impact on a mother’s life and can affect the mother-infant bond, which in turn can have consequences on the physical and emotional development of the child.
The treatment will be sold under the brand name Zurzuvae, and has been approved as a daily pill to be taken over a 14-day period.
The availability of oral treatment represents a significantly more convenient option compared to injectable or intravenous therapies, which may facilitate access to effective treatment for many women.
TEST RESULTS
He most recent study of Phase 3, published last week in the American Journal of Psychiatry, found that a 50-milligram dose of zuranolone was well tolerated and effective. Among 196 women with postpartum depression, those who took 50 milligrams of zuranolone daily for 14 days showed “significant improvements in depressive symptoms” compared to those who took a placebo.
The day after completing the 14-day treatment, 57% of the women reported a 50% or greater improvement in their depressive symptoms, compared with 38% of those taking a placebo. As the investigators continued to be followed up to 45 days, 61.9% of the participants who received zuranolone, compared with 54.1% of those who took a placebo, saw such dramatic improvements in their symptoms.
All in all, this is the second drug to treat postpartum depression. In 2019, Zulresso became the first postpartum depression drug to receive FDA approval. However, that treatment is given as a single 60-hour intravenous drip of the drug brexanolone and has been found to have mild side effects, such as headache, dizziness, or excessive sleepiness.
A SERIOUS CONDITION
It is estimated that each year in the United States more than 400,000 babies are born to mothers with postpartum depression.. In Europe, studies generally report that the prevalence of postpartum depression can range from 10% to 20% of mothers. Without any treatment, postpartum depression can last for months or even years, according to the National Institute of Mental Health.
Postpartum depression is a serious and life-threatening illness in which women experience sadness, guilt, worthlessness, and even, in severe cases, thoughts of harming themselves or their child. And since postpartum depression can disrupt the mother-infant bond, it can also have consequences for a child’s physical and emotional development.
So the approval of zuranolone is a significant step in mental health care for mothersproviding a treatment option that can be more easily adapted to the daily lives of women at this critical stage.
Additionally, it can contribute to greater recognition and treatment of postpartum depression, helping to mitigate the stigma and challenges associated with this devastating condition.
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