In August, the United States FDA approved Zurzuvae (zuranolone), the first specific oral treatment for postpartum depression, which consists of one pill daily for fourteen days. At the moment, the drug has not yet been approved by the European Medicines Agency (EMA).
This is great news, since it is estimated that, worldwide, 17% of new mothers suffer from postpartum depression, a serious depressive episode that usually occurs after childbirth, but can also appear during the later stages of pregnancy.
“Postpartum depression is a serious and life-threatening condition in which women feel sadness, guilt, worthlessness and even, in severe cases, thoughts of harming themselves or the baby. Because postpartum depression can disrupt mother-infant bonding , it can also have consequences for the baby’s physical and emotional development,” said Dr. Tiffany R. Farchione, director of the Division of Psychiatry at the Center for Evaluation and Research. of Drugs of the FDA”
How zuranolone works
Zuranoone is a drug that acts as a derivative of progesterone , a hormone that acts on GABA-A receptors and has been found to be involved in mental disorders such as anxiety and depression. During the postpartum period, there is a sudden drop in progesterone levels, which could be the mechanism by which some women begin depressive symptoms, the Clínic of Barcelona explains .
Prior to the authorization of the drug , two clinical trials were carried out with women with depressive symptoms (the Vall d’Hebron hospital in Barcelona participated in one of them ) and the results have been very encouraging.
At the end of the period, the patients experienced a significant improvement in symptoms, with visible results on the third day, which were sustained until at least a month after the end of the treatment , Vall d’Hebron points out .
In total, more than 300 participants were recruited in Spain, the United States and the United Kingdom, of which half received a placebo and the other the drug. The results demonstrated a significant improvement in the treated group versus the control group and were similar in the two studies. The patient profile was an adult woman with severe postpartum depression strongly induced by hormonal factors.
A hope for many women
In a great advance in the treatment of postpartum depression, taking into account that until now, the only drug used to treat postpartum depression was brexanolone , which could only be administered intravenously and required the mother to be hospitalized. A much more expensive option, which also in Europe could not be administered outside of clinical trials.
Unfortunately, postpartum depression is an underdiagnosed disorder , despite being very common. “We have studies carried out in our country where one in ten women presented diagnostic criteria for a major depressive episode in the postpartum. These are very high figures.” explains Dr. Alba Roca, psychiatrist at the Clínic .
However, the expert points out: “The profile of each woman must be taken into account, it is not a solution to all depressions, and it must be ensured that psychosocial factors are always taken into account and psychological intervention is offered. They are also needed. important studies to know the effectiveness of this drug in the medium and long term.”
