- 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.