Is this new therapy for postnatal depression effective?

The US Food and Drug Administration (FDA) approved zuranolone last August, with the trade name Zurzuvae. The first oral medication indicated to treat postnatal depression. 

Zuranolone is a drug that acts as a progesterone derivative. This is 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 postnatal period, there is a sudden drop in progesterone levels, which could be the mechanism by which some women’s depressive symptoms begin. 

Two randomised clinical trials have been carried out to verify the effectiveness of zuranolone. Both studies found a significant improvement in the reduction of depressive, anxiety and insomnia symptoms in women treated with zuranolone compared to those who had taken placebo. This improvement was observed from 3 hours after administration of the first dose and was maintained for up to 4 weeks after the last dose. 

This new drug is taken in the form of a pill for daily use during a period of 14 days. At the moment, the European Medicines Agency (EMA) has not approved this medicine. Dr Alba Roca, head of the Perinatal Mental Health Unit at the Hospital Clínic Barcelona, highlights that “It is good news to have more therapeutic options for the treatment of severe cases of postnatal depression. Zuranolone may be a good candidate, as cost and administration aspects are improved compared to brexanolone.” 

Until recently, the treatment for postnatal depression was brexanolone, which is administered by intravenous injection only. Therefore, brexanolone is a much more expensive option that requires hospitalisation. Furthermore, in Europe it cannot be administered outside of clinical trials. 

Postnatal depression is a very common and underdiagnosed disorder. Worldwide, the prevalence of postnatal depression is estimated at 17%, although these figures vary. “We have studies carried out in our country where 1 in 10 women had the diagnostic criteria for major depressive episode postpartum. These are very high figures,” explains Dr Roca. 

The most serious complication of postnatal depression, as with general depression is suicide. Contrary to popular belief, motherhood does not protect against suicidal behaviour. Data reveal that suicide represents 20% of maternal mortality in the first year after childbirth. These data are alarming, since it is a preventable cause of death. 

For all these reasons, zuranolone is an important discovery in the treatment of this very common mental disorder. However, Dr Roca clarifies that “The profile of each woman must be taken into account. It is not a solution for all cases of depression, and it must be ensured that psychosocial factors are always taken into account, with psychological intervention being offered. Major studies are also needed to find out the effectiveness of this drug in the medium and long term." 

 INFORMATION DOCUMENTED BY: 

Dr Alba Roca, psychiatrist and head of the Perinatal Mental Health Unit, Hospital Clínic Barcelona