August 4, 2023

FDA Approves Zurzuvae to Treat Postpartum Depression

Zurzuvae has received FDA approval to treat adults with postpartum depression as a rapid-acting, once daily capsule taken for 14 days. Zurzuvae works quickly to improve depression symptoms compared to current treatment options, which may take weeks or months to work. Zurzuvae is the first oral medication that is FDA-approved to treat postpartum depression.

Zurzuvae is thought to work by rebalancing brain networks responsible for functions such as mood, arousal, behavior, and cognition. Some health conditions, such as depression, are thought to be due to imbalances in GABA (Gamma-aminobutyric acid). GABA is a chemical messenger (neurotransmitter) in the brain and spinal cord (central nervous system). Zurzuvae is a neuroactive steroid that acts on the GABA-A receptors as a positive allosteric modulator.

Zurzuvae was developed as an improvement to brexanolone (Zulresso), which is only available as an intravenous injection, whereas Zurzuvae can be taken as a once-daily capsule.

A clinical trial called Study 1 (NCT04442503) looked into the effectiveness of Zurzuvae 50mg for treating postpartum depression in adults. The study found that women who took Zurzuvae 50mg daily for 2 weeks experienced a statistically significant reduction in depressive symptoms by day 15.

  • Zurzuvae 50mg reduced the HAMD-17 score by −15.6 compared to the placebo score, which decreased by −11.6, a difference of -4.0.
  • Symptoms of depression improved from day 3 and lasted through to day 42.

The daily recommended dose for Zurzuvae is 50mg. It should be taken once every day, for 14 days, in the evening with a fatty meal.

Zurzuvae may cause serious side effects, including Increased risk of suicidal thoughts or actions and decreased ability to drive or do other dangerous activities.

Zurzuvae is expected to become commercially available as a prescription in the fourth quarter of this year.

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