Zurzuvae: First Oral Postpartum Depression Pill Authorized by the FDA

Carrying and birthing a child definitely takes a toll on the body, and this includes the emotional and mental health impact. With the incidence of postpartum psychiatric illnesses on the rise, it is important to find therapies and treatments that can help to address the issue. The Food and Drug Administration (FDA) recently approved the first oral medication aimed at treating postpartum depression.

Postpartum Depression Is A Maternal Health Crisis

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child, and, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.” – Dr. Tiffany Farchione, director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research. 

Postpartum depression (PPD) is the most common psychological condition following childbirth, affecting 17.22% of the world’s population. Unlike the “baby blues”, which only last a week or so after the baby is born, postpartum depression is more intense and lasts longer, and it can impact one’s daily life. In the United States, postpartum depression impacts 10-15% of women, and the condition is the leading cause of pregnancy-related deaths.

Per the Mayo Clinic, symptoms of postpartum depression include:

• Depressed mood or severe mood swings
• Crying too much
• Difficulty bonding with your baby
• Withdrawing from family and friends
• Loss of appetite or eating much more than usual
• Inability to sleep, called insomnia, or sleeping too much
• Overwhelming tiredness or loss of energy
• Less interest and pleasure in activities you used to enjoy
• Intense irritability and anger
• Fear that you’re not a good mother
• Hopelessness
• Feelings of worthlessness, shame, guilt or inadequacy
• Reduced ability to think clearly, concentrate or make decisions
• Restlessness
• Severe anxiety and panic attacks
• Thoughts of harming yourself or your baby
• Recurring thoughts of death or suicide

Unfortunately, despite the alarming realities of postpartum depression, up to 50% of women with the condition go undiagnosed and untreated. Yet, it appears that the FDA’s latest mandate may help address this issue.

FDA Approves Zuranolone To Treat Postpartum Depression

A month ago, Zulresso (brexanolone) was the only federally approved option for postpartum depression. The treatment is available through an intravenous infusion worth $34,000 and has side effects that include hives, difficulty breathing, lightheadedness, and excessive drowsiness.

Now, this past week, the FDA approved the drug Zurzuvae (zuranolone) by Sage Therapeutics and Biogen. The oral medication is indented to “provide rapid improvements” in women dealing with symptoms of postpartum depression.

What did the research show?

The FDA received data from clinical trials published in The American Journal of Psychiatry. The study featured 543 mostly White mothers with a mean age of 40 and living with major depressive disorders (MDD) and postpartum depression. The women were each randomly assigned oral Zurzuvae 50 mg or placebo once daily for 14 days.

Photo by Kelly Sikkema on Unsplash

According to the study’s findings, the women who received Zurzuvae experienced significantly greater improvement in depressive symptoms at 15 days compared to the placebo group. What’s more, the effect continued after the patients ceased taking the Zurzuvae, throughout the 45 days that they were monitored in the trials. 

The main side effects of Zurzuvae noted during the study were sleepiness and dizziness. The FDA shared that the packaging for Zurzuvae will feature a boxed warning noting that the drug can affect a user’s ability to drive and perform other potentially hazardous activities.

How does it work?

According to Dr. Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill and a lead investigator for the clinical trials, Zurzuvae contains a synthetic version of a brain hormone called allopregnanolone, which works to regulate a mood-related neurotransmitter.

Managing Postpartum Depression

While the FDA’s approval is a win for maternal health, it should be noted that the clinical trials were short-term. The participants were also severely depressed at the start of the study, which may limit their application to those with mild or moderate symptoms. 

Additionally, some doctors do not feel that Zurzuvae would be appropriate for everyone dealing with postpartum depression. Rather, those with mild to moderate depression can still opt for other options like talk therapy. 

Speaking to the New York Times, Dr. Kimberly Yonkers, chairwoman of the psychiatry department at the University of Massachusetts Chan Medical School, admitted that she would not likely recommend Zurzuvae to patients dealing with longstanding recurrent depression or for “somebody who has a severe episode with a suicidal attempt or hospitalization because you don’t give them a treatment for two weeks and then stop it.”

Rather, she said that appropriate patients might include “people who have not had a complete response to another antidepressant.”

That said, there is a belief that Zurzuvae could work as a bridge to longer-term antidepressants in some people.

ARE YOU A NEW PARENT WHO NEEDS HELP?

If you’re a new parent and struggling with your mental health, you can reach the Postpartum Support International helpline by calling or texting 800-944-4773. If you or someone you know is in crisis, please call, text, or chat with the Suicide and Crisis Lifeline at 988, or contact the Crisis Text Line by texting TALK to 741741.

MAIN IMAGE CREDIT: Photo by Gustavo Fring

References

Clayton, A. H., Lasser, R., Parikh, S. V., et al. (2023). Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo-Controlled Phase 3 Trial. The American journal of psychiatry, appiajp20220459. Advance online publication. https://doi.org/10.1176/appi.ajp.20220459

Sudhanthar, S., Sheikh, Z. E., & Thakur, K. (2019). Postpartum depression screening: are we doing a competent job?. BMJ open quality, 8(4), e000616. https://doi.org/10.1136/bmjoq-2018-000616

Wang, Z., Liu, J., Shuai, H., Cai, Z., Fu, X., Liu, Y., Xiao, X., Zhang, W., Krabbendam, E., Liu, S., Liu, Z., Li, Z., & Yang, B. X. (2021). Mapping global prevalence of depression among postpartum women. Translational Psychiatry, 11(1), 1-13. https://doi.org/10.1038/s41398-021-01663-6