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FDA Close To Approving First Drug Made for Postpartum Depression

Doctors have long treated postpartum as though it were clinical depression, when it may not be at all.

A Massachusetts-based biotech company, Sage Pharmaceuticals, is nearing achieving FDA approval on a new drug that would tackle a very common but not deeply understood mood disorder: postpartum depression. About 10 to 20 percent of new moms report experiencing depression, anxiety, and an inability to bond with their baby after giving birth. These symptoms can be mild to severe and can last up to half a year. Many of those women have had no previous history of mental illness. Scientists have struggled to understand if postpartum is different than run-of-the mill clinical depression, but with this new drug, which is being considered a breakthrough therapy, they might be closer.

In the past, doctors have taken to prescribing normal SSRI’s to new moms, which are often used in treatment of regular clinical depression. Sage developed an alternative called brexaolone, has just passed phase III clinical trials, and is expected to be approved by mid-December.

According to Quartz, the drug works differently than SSRI’s in that SSRI’s extend the power of serotonin in the brain. Meanwhile, brexaolone targets GABA, which is a hormone that signals the brain to calm down. During pregnancy, the brain is flooded with chemicals for the baby and the mom, and after giving birth, the chemical readjustment for some new moms can be tough. GABA receptors, which were dampened during pregnancy, reactivate but with complications, and moms can feel anxiety and depression as a result of that chemical readjustment.

The women who participated in the trial received the brexaolone through an IV over 60 hours and reported feeling fewer symptoms of depression. Sage hopes to develop the drug into a pill form.