The Food and Drug Administration (FDA) has approved the first pill to treat postpartum depression (PPD), the agency announced Friday.
Zurzuvae is the market’s first pill medication for the disorder that can occur, in mild cases, in as many as 50 percent of new mothers.
“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,” FDA Director of Psychiatry Tiffany Farchione said in a statement.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
Two randomized studies determined that Zurzuvae is effective at combating PPD, the agency said, with one study showing about a 55 percent improvement in symptoms among women with PPD.
The once-a-day pill can help alleviate depressive symptoms in days, instead of weeks or months like the traditional antidepressants usually prescribed for the disorder.
Manufacturer Sage Therapeutics released a similar drug in 2019, the first ever to combat PPD. But that product, Zulresso, is an IV injection, inconvenient for most new mothers.
Zurzuvae will now go into the Drug Enforcement Agency approval process, which is expected to take about 90 days.
Last year, the FDA approved the first fast-acting pill to combat clinical depression. That medication, using a novel mechanism of treatment, could open the door to a whole suite of new treatments for depression, experts said.
