FDA approves first new drug developed for women with postpartum depression
he Food and Drug Administration on Tuesday approved brexanolone, the first drug specifically targeted to treat postpartum depression — the most common complication of childbirth. Yet it’s a condition that often goes untreated because new mothers fear being stigmatized if they report symptoms.
Brexanolone is the first drug developed by and approved from Sage Therapeutics. The Cambridge, Mass.-based biotech company will market the new medicine under the brand name Zulresso.
“This approval is important for postpartum depression patients and it’s important for our company. It’s rare in your career when you can introduce a new medicine that is different from what’s out there,” said Sage CEO Jeff Jonas.
Approximately 400,000 women experience postpartum depression each year in the U.S., according to the Centers for Disease Control and Prevention. But specialists say only about half of women with postpartum depression are diagnosed and treated. They hailed Zulresso’s arrival because it works fast and should spark more awareness and diagnosis of the disease.
“This is a game-changing drug,” said Dr. Marcela Almeida, a psychiatrist at Brigham and Women’s Hospital in Boston. “Current antidepressants can take weeks to be effective. [Zulresso] works within a couple of days, and women see significant improvements in three days. This is important because it’s a crucial period for a new mother’s relationship with her baby.” Almeida has no financial ties to Sage.