A new drug to treat a condition that affects around 600,000 new moms each year just passed a major hurdle

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  • A new treatment for postpartum depression just got one step closer to approval after succeeding in a late-stage clinical trial on Thursday.
  • The drug, brexanolone, is given as an infusion to new mothers who experience long-lasting symptoms of depression after giving birth.
  • If the FDA give it the OK, it would be the first drug specifically approved to treat postpartum depression.

Postpartum depression, a condition that happens to women in nearly 15% of the 3.9 million births that happen each year in the US, just got past a major hurdle to potentially having its own approved drug.

Giving birth can trigger emotions for new moms that include depression, which often goes away after a few days or weeks. Postpartum depression on the other hand, tends to last longer, leading to a depressed mood or mood swings, trouble bonding with the baby, overwhelming fatigue, and other concerning behaviors, according to the Mayo Clinic .

According to the National Institutes of Mental Health , postpartum depression is generally treated with antidepressants and counseling. But new data from a company called Sage Therapeutics could open up another treatment option for women who experience moderate to severe postpartum depression.

In two late-stage, phase 3 clinical trials of more than 20o women, researchers found that women who received the injected therapy, called brexanolone, had a decrease in depressive symptoms over a 30-day compared to the women who were on the placebo control.

Sage's stock jumped more than 50% on Thursday on the news.

"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," Sage CEO Dr. Jeff Jonas said in a news release on Thursday.

Brexanolone has also been tested to treat a certain kind of epilepsy, though in September it failed a key late-stage study .

With these postpartum depression results, Sage expects to submit the drug for approval in the first half of 2018.

Dr. Brian Abrahams, an analyst at RBC Capital Markets said in a note that he expects, if brexanolone is approved, the drug to make about $650 million in peak sales, with a price of about $15,000 to $20,000 for an infusion of the drug.

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