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First Drug for Postpartum Depression May Soon Become a Reality

Photograph by Twenty20

With pregnancy comes a massive amount of physical, mental and emotional disruption, thanks to the frequent hormone parties that your body throws after conception. What comes afterward, however, once the baby is born, remains a mystery.

For some, motherhood is everything they could ever hope to imagine. For others, they can't stop crying and have no idea why.

Unlike the "baby blues"—a physical response to hormone changes and the many sleepless nights brought on by caring for a newborn (typically lasting a week or two)—postpartum depression (PPD) is a severe mood disorder that lingers. Without treatment, it can last anywhere from a couple of months to a few years, causing extreme sadness, anxiety, irritability and exhaustion.

Because symptoms of PPD are similar to that of clinical depression, women are often treated with mood stabilizers, antidepressants and antipsychotics, but this might be changing before the end of the year.

Symptoms of PPD should not be overlooked by new moms or those in their support networks.

Sage Therapeutics, a clinical-stage biotech company located in Cambridge, Massachusetts, announced that the U.S. Food and Drug Administration is one step closer to approving its application for an intravenous form of brexanolone, the first medication designed to treat PPD.

If approved, the company says the drug “may offer significant improvements in the treatment, prevention or diagnosis of this serious condition.” It will also be Sage's first commercial product, and the FDA has granted "priority review" for the drug and set an action date of December 19.

“PPD is commonly viewed as a disorder solely experienced by the mother, but it also seriously impacts the child and family members—both immediate and extended," said Dr. Samantha Meltzer-Brody, associate professor and director of University of North Carolina perinatal psychiatry program at the UNC Center for Women’s Mood Disorders and primary investigator of the studies, in a 2017 statement. “Symptoms of PPD should not be overlooked by new moms or those in their support networks, and the healthcare community should encourage discussion and appropriate action.”

Dr. Jeffrey Jonas, chief executive officer of Sage, added that he was pleased with their findings, specifically those relating to the Hummingbird Program, which included two Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled trials designed to evaluate the safety and effectiveness of brexanolone in women with moderate and severe PPD.

“We believe the data represent an unprecedented opportunity in the development of treatments for PPD, and may serve as the catalyst for a paradigm shift in how the disease is approached and, if approved, may change how PPD is treated," Jonas said in a statement.

Still, the FDA has a lot of work to do before giving this drug its final stamp of approval. In addition to reviewing the company trials, the FDA will host their own rigorous inspection, conducted by expert panels to ensure that the product passes all safety regulations.

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