The exact causes of postpartum depression are not yet clear, although over the years physical and emotional factors have been identified that can contribute to its development. After giving birth, the combination of hormones in the body changes significantly, in some cases affecting mood and sleep / wake cycles. Other risk factors are the presence of mild psychological disorders or a family history with cases of depression. Mothers suffering from postpartum depression usually show sudden mood swings, loss of appetite, insomnia and sometimes a lack of interest in the newborn. In the most serious cases, and if not treated properly, postpartum depression can lead to deeper and prolonged depressive states, up to acts of self-harm.
The active ingredient of the drug is brexanolone, a compound similar to allopregnanolone, a steroid naturally produced by our body and which has the ability to modify the activation states of neurons. As with many other antidepressant drugs, we do not know exactly how it works, but we can see the effects and possible benefits on patients. Brexanolone contributes to slowing down neuronal activity, reducing anxiety and other factors that lead to episodes of depression.
The Zulresso was developed by the pharmaceutical company Sage Therapeutics, which also performed the studies and clinical tests whose results were then submitted to the FDA for approval. The main clinical test involved 247 women, randomly divided into two groups: the first received the real drug, the second a substance that produced no effect (placebo). The participants had all become mothers in the six months before the start of the test and had various forms of post-partum depression. Mothers with previous episodes of depression and attempted suicides were excluded from the selection.
After drug administration, improvements were seen in both groups, a fairly common phenomenon when experimenting with drugs against depression and using a control group that takes a placebo. However, the number of women who showed noticeable improvements was greater among the patients who had taken the real drug, with measurable progress over time.
In another test, participants with a high degree of depression, up to 28 out of 30, on the scale most commonly used to assess depressive states, showed noticeable improvements after taking Zulresso. They achieved a score of 9-10 out of 30, while in the placebo control group we stopped at 14. Usually, a person with a score below 7 is considered to be free of depressive symptoms.
In the documentation submitted to the FDA, the researchers explained that one month after taking brexanolone, the patients showed depressive symptoms under control, more than those who took the placebo. In the case of patients with moderate depression, however, the placebo proved to be substantially as effective as the drug 30 days after taking it.
Zulresso can only be administered in a hospital by infusion and under medical supervision. The drug can cause a slight dizziness in the hours immediately after taking it. A pill, which would make hiring much more practical, is still under development. A cycle of Zulresso has a cost of 34 thousand dollars, a figure that does not include the cost of hospitalisation for its administration. In the United States, the expense is borne by insurance companies, depending on your insurance plan, and the pharmaceutical company may agree different rates depending on the commercial agreements. It is not yet clear when and if the Zulresso will be approved in Europe. Sage Therapeutics has already initiated contacts and collaborations with the European Medicines Agency (EMA).