The FDA has given its approval for the first-ever pill designed specifically to treat severe depression after childbirth. This condition, known as postpartum depression, affects thousands of new mothers in the U.S. each year.
The newly approved drug, called Zurzuvae, is intended for adults experiencing severe depression related to pregnancy or childbirth. It is a once-daily pill taken for a period of 14 days.
Dr. Tiffany Farchione, the FDA’s director of psychiatric drugs, stated that having an oral medication option will be beneficial for women dealing with these extreme and potentially life-threatening feelings.
Postpartum depression affects an estimated 400,000 individuals annually. While it often resolves itself within a few weeks, it can persist for months or even years. Current treatment options include counseling or antidepressants, but these can take weeks to work and are not effective for everyone.
Zurzuvae is developed by Sage Therapeutics, the same company that created a similar infused drug administered intravenously over three days in a medical facility. The IV drug, approved by the FDA in 2019, is not widely used due to its high cost and logistical challenges.
The FDA’s approval of the Zurzuvae pill is based on two studies conducted by the company. These studies showed that women who took the pill experienced fewer signs of depression over a four- to six-week period compared to those who received a placebo. The benefits, measured using a psychiatric test, were observed in as little as three days for many patients.
Dr. Kimberly Yonkers from Yale University, a specialist in postpartum depression, described the effect of Zurzuvae as “strong” and predicted that it would likely be prescribed for women who have not responded to traditional antidepressants. However, she also expressed concerns about the lack of long-term data on the drug’s effectiveness beyond 45 days.
The pricing of Zurzuvae has not yet been announced by Sage Therapeutics, but it is considered a crucial factor in determining its widespread use.
Compared to the IV version, the side effects of the oral drug are milder and include drowsiness and dizziness. The drug was developed in collaboration with the Massachusetts pharmaceutical company Biogen.
Both the pill and IV versions of Zurzuvae emulate a derivative of progesterone, a naturally occurring female hormone crucial for maintaining pregnancy. After childbirth, levels of this hormone can significantly drop.
Sage’s drugs belong to a new class of medications called neurosteroids, which target a different brain pathway than older antidepressants focusing on serotonin, a chemical associated with mood and emotions.
Related Articles:
