First-ever pill for postpartum depression is up for FDA approval this week

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The Food and Drug Administration is expected to decide by Saturday whether to approve the first-ever pill for postpartum depression.

involving women who experienced severe depression after having a baby, the drug improved symptoms — such as anxiety, trouble sleeping, loss of pleasure, low energy, guilt or social withdrawal — as early as three days after the first pill.

The medication was jointly developed by pharmaceutical companies Biogen and Sage Therapeutics. If approved, it will become the first treatment for postpartum depression that can be taken at home. The only other available option is that the FDA approved in 2019. It requires patients to stay in a hospital for two-and-a-half days.

Dr. Samantha Meltzer-Brody, director of the University of North Carolina’s Center for Women’s Mood Disorders and an investigator on both zuranolone trials, said the data so far are"incredibly encouraging and very exciting," though she cautioned that the trials only followed patients for 45 days.

 

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