FDA approved drug for the treatment of postpartum depression for the first time: cook $ 34 thousands

The US Food and Drug Administration (FDA) for the first time approved a treatment for postpartum depression. N + 1 with reference to the press release of the organization.

Фото: Depositphotos

The drug Zulresso (Zulresso) begins to act within a few days, after the 60-hour dropper. Due to the duration of intravenous infusion, as well as due to side effects, the drug will be used for the treatment of a limited number of patients in certified clinics.

Postpartum (or postnatal) depression develops within a month after giving birth in approximately 10-15 percent of mothers and 1-26 percent of fathers. Among the symptoms of the disease are disorders of sleep and appetite, depression, irritability, fatigue, suicidal thoughts. The causes of postpartum depression are not precisely known. Risk factors include depression or bipolar disorder in a family history of the disease, stress, psychological or physical trauma during pregnancy. At the moment, psychotherapy and antidepressants are used to combat postpartum depression.

The FDA has approved a new drug, zulresso, which is manufactured by Sage Therapeutics to treat this disease. This is a synthetic analogue of the neurosteroid allopregnanolone. It affects the activity of the GABA-A receptor, which, in turn, is controlled by GABA (gamma-aminobutyric acid, the main neurotransmitter of the brain) and inhibits the transmission of nervous excitement.

As phase 3 clinical trials have shown, Zulresso begins to act within 60 hours. The drug was tested on 375 women with severe and moderate forms of the disease. They were given intravenous fluids for 60 or 90 hours or were given a placebo. The drug began to act after the completion of the procedure, and its effect lasted for four weeks (for so long the doctors watched the subjects). Among the side effects were dizziness, headache and drowsiness. One of the subjects was observed altered state of consciousness and fainting.

Фото: Depositphotos

Due to side effects and complex drug administration, patients will have to stay in the hospital for 60 hours. While he was approved for the treatment of a limited group of people and only in certified clinics. After the dropper, patients are not recommended to get behind the wheel or work with the equipment until the induced sulresso drowsiness passes.

The cost of one dropper (excluding hospital stay) is $ 34 thousand. Given the high cost of the drug, the manufacturing company expects that insurance companies will cover the treatment.

According to doctors, Zulresso can help 30 percent of women suffering from postpartum depression. In particular, those who suffer from a severe form of the disease, or who are not helped by conventional antidepressants.

“Perhaps this is a suitable treatment for patients with resistance, or those who cannot wait for 2-4 for a week while antidepressants work,” says Dr. Kimberly Yonkers, a professor of psychiatry at Yale University.

In early March, the FDA approved the dissociative substance estetamine as an antidepressant. The drug will be used to treat patients with resistant depression.

Previously, ForumDaily talked about childbirth in the USA and medicine in the first year of a child’s life, as well as real stories of our immigrants who come to give birth in the US and how much it cost them.

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