The 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.
“One of the difficulties with psychiatric illness is that we often don’t know what causes it or why someone becomes ill,” said Dr. Lucy Puryear, medical director of The Women’s Place, Center for Reproductive Psychiatry at Texas Children’s Pavilion for Women. “With postpartum depression, having an illness that is most likely linked to a hormonal trigger and can be treated with a hormonal therapy like [Zulresso] goes a long way toward decreasing stigma, increasing acceptance of the diagnosis, and encouraging women to seek help.” Puryear has no financial ties to Sage; her hospital participated in the Zulresso clinical trial.
There are logistical challenges and safety precautions that might limit the use of Zulresso. The drug is administered via an intravenous infusion over 60 hours. Zulresso can cause dizziness, drowsiness, sedation, and fainting, so the FDA is requiring women to be treated at an inpatient facility or hospital where they can be monitored.
Across three clinical trials that enrolled more than 200 women with postpartum depression, Zulresso demonstrated a reduction in HAM-D total score, a common measure of depression severity, by an average of 17 points compared to just under 13 points for a placebo. The statistically significant benefit favoring Zulresso continued for 30 days when treatment stopped at 60 hours.
Zulresso is a proprietary formulation of the neurologic steroid allopregnanolone and works by modulating neurotransmitters in the brain called GABA receptors — the brain’s main inhibitory system — differently than currently approved anti-seizure medications.