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The FDA approves the first postpartum depression drug



The treatment is administered as a single 60-hour IV drop and was found to have mild side effects, such as headache, dizziness or excessive sleepiness. Nevertheless, some women may face barriers that access this type of treatment as it requires 60 hours of time. The drug is likely to be priced around $ 20,000 to $ 35,000 per treatment, Sage Therapeutics, the firm that developed the drug confirmed.

The initial listing price for Zulresso in the US will be $ 7,450 per vial, resulting in an expected average rate of therapy cost of $ 34,000 per patient before discounts, according to the company. The actual number of vials used before discounts may vary from patient to patient.

"There are no FDA-approved antidepressants for postpartum depression, so the approval of the first drug of its kind is a breakthrough for patients," said Dr. Kristina Deligiannidis, director of women's behavioral health at Northwell Health's Zucker Hillside Hospital in New York. who were involved in two of the drug's clinical trials as a researcher.

Without treatment, postpartum depression may last for months or even years, according to the National Institute of Mental Health. Studies showed that brexanolone was effective regardless of when postpartum depression symptoms began.
In the United States, it is estimated that every year, over 400,000 infants are born to mothers who are depressed. Postpartum depression treatment options have included counseling or therapy with psychiatric professional and antidepressant drugs, but no antidepressant medication has been specifically FDA approved for the treatment of postpartum depression. Also, antidepressant medications usually do not provide immediate relief of symptoms, and may take several weeks to help.
"Brexanolone in Phase II and III studies showed rapid antidepressant effect," said Deligiannidis, who is also an associate professor at the Feinstein Institute for Medical Research and a member of the Anxiety and Depression Association of America.

These effects are something that Stephanie Hathaway, a Connecticut-based mother of two, knows well.

A "breakthrough" drug is being tested [1
9659009] When Hathaway brought her first baby home from the hospital, she was as excited and nervous as most new mothers – but she also experienced crying words and worrying thoughts that she couldn't shake.

"The first two weeks I cried too much," says Hathaway. First, the man and she thought that her tears were from "baby blues", a feeling of sadness or emptiness after birth that goes away in a few days. [19659009] "But after I had intrusive thoughts," she said. "They were," Your daughter deserves a better mother, "and" Your husband deserves a better wife. ""

Then Hathaway knew she needed help when she one day her daughter and she feared what she could do for herself when she let her baby down.

  Stephanie Hathaway holds her first-born child, Hadley

In 2014, Hathaway was diagnosed with postpartum depression and was treated with traditional antidepressant drugs, which she said helped "over time."

Some years later, in 2017, Hathaway had a second child , and was prescribed the same antidepressants in running t of pregnancy – but the medications were not helpful in alleviating her symptoms.

A friend told Hathaway about clinical trials conducted to evaluate the effectiveness of brexanolone in the treatment of postpartum depression. Hathaway signed up for a trial period.

"It was a 60-hour infusion, and in the first 12 to 18 hours I felt the biggest difference," Hathaway said.

"The intrusive thoughts that played on repetition in my head, they passed away and did not come back," she said, adding it as a side effect, "I only had a small incidence of getting up and feeling light."

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