First oral treatment for women with postpartum depression approved by FDA

Betsy Goodfellow | August 7, 2023 | News story | Research and Development FDA, postpartum depression, treatment, zurzuvae 

On 4 August 2023, the US Food and Drug Administration (FDA) approved the use of Zurzuvae for adults with postpartum depression (PPD); approval was granted to Sage Therapeutics who are currently at phase 3 of what they are calling the SKYLARK study.

50mg of the treatment should be taken every evening for 14 days in total and patients should not drive or partake in hazardous activities for at least 12 hours after the dosage. The drug’s efficacy for the treatment of PPD was determined in a set of randomised, double-blind, placebo-controlled studies. One group was given Zurzuvae for 14 days while the other was given a placebo dose. Results demonstrated that Zurzuvae led to significant improvement of PPD symptoms.

The treatment does, however, come with numerous side effects including dizziness, diarrhoea, fatigue, urinary tract infection, and more. In extreme cases, taking Zurzuvae could potentially lead to foetal harm and suicidal thoughts and behaviours.

In the US, approximately one in eight women suffer from PPD, with 70% not even being diagnosed; these women will experience symptoms such as cognitive impairment, feelings of sadness or inadequacy, lack of energy or even suicidal ideation.

Tiffany R Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, commented: “Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child… having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Rebecca Lee

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