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FDA Approves First Oral Treatment for Postpartum Depression

7 Aug 2023 • The U.S. Food and Drug Administration has now approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults on Friday, the 4th of August 2023. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.

As with other forms of depression, PPD is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure. It can present with symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy or suicidal ideation.

The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at Day 42—four weeks after the last dose of Zurzuvae.

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. The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infection.

Source: FDA | Read full story

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