US FDA Approves First Oral Pill for Postpartum Depression Treatment

The U.S. Food and Drug Administration (FDA) on the 4th (local time) approved, for the first time ever, an oral medication for the treatment of postpartum depression. Foreign media such as The New York Times (NYT) and AFP reported that this opens the door to treating up to 500,000 patients annually in the United States.

The new antidepressant 'zuranolone,' jointly developed by U.S. pharmaceutical companies Sage and Biogen, is planned to be released within the year under the name 'Zurzuvae.' According to the media, zuranolone works by using neurosteroids to regulate gamma-aminobutyric acid (GABA), a neurotransmitter in the brain, thereby producing therapeutic effects.

Clinical trial results showed that the drug's effects appeared very quickly, with depression symptoms beginning to ease within three days. This is much faster than other antidepressants, which typically take more than two weeks to show effects.

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Previously, a Phase 3 clinical trial conducted by a research team led by Professor Anita Clayton, a psychiatry specialist at the University of Virginia School of Medicine, involving 543 patients (aged 18?64) with major depression, found that zuranolone had rapid and long-lasting effects.

Psychiatrists expect many patients to actively engage in treatment since the medication period is set at two weeks rather than several months.

The FDA described zuranolone as "the first oral pill shown to treat postpartum depression in adults," noting that "until now, postpartum depression treatments could only be administered via intravenous injection in specific medical facilities."

This antidepressant's approval as a treatment for postpartum depression is highly significant. Some women blame themselves for symptoms of postpartum depression.

Postpartum depression, which occurs between 4 weeks and 12 months after childbirth, is accompanied by symptoms such as sadness, anxiety, and extreme fatigue. In severe cases, mothers may neglect or harm their newborns and may even resort to extreme measures. In the United States, 10?15% of women experience depression during pregnancy or after childbirth.

Before zuranolone, the only FDA-approved treatment for postpartum depression was Zulresso, an intravenous injection that required continuous administration for 60 hours. It carries a risk of loss of consciousness and costs up to $34,000, and since its release, only about 1,000 patients have been treated with it.

In contrast, zuranolone is taken once daily for a minimum of two weeks. AFP reported that Tiffany Farchione, head of the mental health division at the FDA's Center for Drug Evaluation and Research, stated, "Access to an oral medication will be a beneficial option for many people fighting severe depression that can sometimes be life-threatening."

Meanwhile, doctors recommend that patients with mild or frequently recurring postpartum depression symptoms consider bold treatment approaches.

This content was produced with the assistance of AI translation services.