The Food and Drug Administration (FDA) de USA (EU) has approved the drug zuranolone, under the brand name Zurzuvae, for him postpartum depression treatment (DPP), the first approved oral pill specifically for this perinatal mood disorder.
The treatment is a pill that is taken once a day for 14 days. According to data from the US Centers for Disease Control and Prevention (CDC), one in eight women in the US experience symptoms of this form of depression.
The most common symptoms of PPD are sadness, lack of energy or even suicidal thoughts. “It is a serious and life-threatening condition in which women experience sadness, guilt, worthlessness and even, in severe cases, thoughts of harming themselves or their children,” explains the Dra. Tiffany R. Farchionehead of the Division of Psychiatry of the Center for Drug Evaluation and Research from the FDA.
The drug Zulresso, similar operation but by a different route of administration
Like any other medication, the pill also has its contraindications. Thus, the FDA has added a warning box on the medication label, noting the most common side effects including drowsiness, seasickness, diarrhea or fatigue.
Already in 2019, the drug Zulresso it became the first treatment for postpartum depression to receive FDA approval, but it is not an oral pill. Both drugs work in a similar way but are administered differently.
Unlike Zurzuvae, this medicine is given 60 hour intravenous drip with mild side effects, but unlike zuranolone, it should be used only in hospitals and requires having those hours to manage it.
Allopregnanolone, the substance that could contribute to postpartum depression
Both drugs are versions of a natural substance in the body called allopregnanolone. The levels of this substance can rise sharply during pregnancy and then fall sharply after delivery, leading to could contribute to postpartum depression.
Therefore, with these medicines, which have a similar structure to allopregnanolone, the aim is to restore the levels of this substance in the woman’s body.
At the moment the expectations are good. Clinical trials show that the pill helped significantly reduce depressive symptoms in three days, and the effect of the medication was maintained for four weeks dafter the last dose, the FDA explained. However, there is still no substantial evidence of effectiveness, so additional studies would be needed.
Zurzuvae’s FDA approval is a big step for the field of maternal mental health, and at the moment it is unknown if it will be approved in Europe. According to drug manufacturers Sage Therapeutics y BiogenIt is expected that Zurzuvae is available at the end of this 2023.
