First pill to treat postpartum depression moves to FDA for review

(NEW YORK) — A first-of-its-kind pill designed to help treat postpartum depression is one step closer to being available to new mothers.

The drug, called Zuranolone, is now being reviewed by the U.S. Food and Drug Administration, which has until Aug. 5, 2023, to decide whether or not to approve the drug based on an evaluation of its effectiveness and safety.

If approved, Zuranolone, made by Sage Therapeutics, Inc., and Biogen Inc., would be the first pill to treat postpartum depression, a type of depression that occurs after having a baby, according to the Centers for Disease Control and Prevention.

The fast-acting antidepressant would be taken once a day for two weeks.

“We feel a tremendous responsibility to patients with MDD and PPD to deliver a potential new treatment option, which is so desperately needed. Most current approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly,” Dr. Laura Gault, chief medical officer at Sage Therapeutics Inc., said in a statement. “We believe Zuranolone, if approved, could offer a new way for physicians to support patients.”

The medication would also be much handier than other treatments.

Currently, there’s only one drug on the market that’s FDA-approved to treat postpartum depression. The drug, called Zulresso, is only available through a 60-hour, one-time infusion, and can cost as much as $20,000 to $35,000 per treatment.

Postpartum depression affects as many as 1 in 8 women who give birth, according to the CDC.

Symptoms of postpartum depression include withdrawing from loved ones, crying more than usual, feeling worried or overly anxious, feeling anger, doubting your ability to take care of your baby and thinking about harming yourself or your baby, according to the CDC. The symptoms may last for weeks or months after giving birth, and are more intense and longer lasting than the “baby blues” that women may experience after giving birth.

Current treatment for postpartum depression can include talk therapy or antidepressants, according to the National Institutes of Health. While a number of antidepressants may be helpful for the condition, they can take weeks to work.

Zuranolone was found in at least one clinical trial to show promising results.

A trial published in 2021 found that after two weeks of daily treatment using Zuranolone, women treated with the medication had a “statistically significant reduction in their core symptoms of depression compared to women who received a placebo.”

After 45 days, 53% of women who received Zuranolone were in full remission of clinical depression versus 30% who received the placebo, according to the study, published in the Journal of the American Medical Association Psychiatry.

The clinical trial found Zuranolone was “generally well tolerated” in the women who took it, with some reported side effects including drowsiness, headache, dizziness and upper respiratory tract infection.

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