US approves postpartum depression pill
Posted on the 15th August 2023
The U.S. Food and Drug Administration (FDA) has approved the first pill for postpartum depression.
Zuranolone, sold under the brand Zurzuvae, has been approved as a once-daily pill taken for two weeks. Drug manufacturers Sage Therapeutics and Biogen said the pill is expected to be available later this year.
Currently, treatment for postpartum depression (PPD) is available only as an intravenous injection.
Similar to other forms of depression, symptoms of PPD can include sadness, loss of energy, suicidal thoughts, decreased ability to feel pleasure, and cognitive impairment, according to the FDA.
It is estimated that one in seven women in the USA experience symptoms of PPD.
Clinical trials showed the pill helped to significantly reduce depressive symptoms within three days. The effect of the medication was maintained at four weeks after the last dose, the FDA said.
It noted that the most common side effects from taking Zurzuvae can include drowsiness, dizziness, diarrhoea, fatigue, the common cold, and urinary tract infection.
The agency said labelling contains a boxed warning noting that Zurzuvae can affect a person's ability to drive and perform other potentially hazardous activities. It recommends patients should not drive or operate heavy machinery for at least 12 hours after taking it.
Sage Therapeutics and Biogen had also sought approval to use zuranolon for major depressive disorder (MDD), or clinical depression.
However, the FDA said that the medication did not provide substantial evidence of effectiveness and that an additional study or studies would be needed.
The companies said they were evaluating their next steps.
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