The US Food and Drug Administration (FDA) has given the green light for the medication zuranolone to be used in the treatment of postpartum depression. This marks a significant milestone as zuranolone becomes the first FDA-approved oral pill in the United States tailored specifically for this debilitating mental illness, affecting about 1 in 7 new mothers after childbirth.
Sold under the brand name Zurzuvae, the medication has been approved as a once-daily pill to be taken over a 14-day period. Postpartum depression is a severe condition that can lead to feelings of sadness, guilt, and worthlessness. In severe cases, it may even trigger thoughts of self-harm or harm to the child, impacting the maternal-infant bond and the child's emotional development.
Dr. Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, emphasized the importance of this milestone, stating that having an oral medication option will be beneficial for women facing extreme and potentially life-threatening feelings.
Key Statistics and Findings
- The new medication zuranolone, designed to combat postpartum depression, has been found safe and effective in Phase 3 trials.
- The FDA warns that the drug may impair a person's ability to drive or perform hazardous activities, and patients should not operate heavy machinery for at least 12 hours after taking the drug.
- Common side effects include drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infection.
- The drug may lead to suicidal thoughts and behavior and may cause harm to the fetus. Women should use effective contraception while taking it and for one week after.
- Approximately 20% of postpartum deaths are attributed to maternal suicide.
- Each year, more than 400,000 babies are born to depressed mothers in the United States, and without treatment, postpartum depression can last for months or even years.
Zuranolone and its Predecessor Zulresso
In 2019, Zulresso became the first FDA-approved drug for postpartum depression. It requires a 60-hour IV drip of brexanolone and was found to have mild side effects, including headache, dizziness, and excessive sleepiness.
The recent approval of zuranolone marks it as the nation's second postpartum depression drug and is seen as a game-changer due to its easy-to-use pill form, allowing at-home treatment.
Promising Results from Trials
Clinical trials for zuranolone demonstrated rapid and significant reductions in depressive symptoms, with improvements observed within three days and lasting up to 45 days after treatment.
Dr. Samantha Meltzer-Brody, a researcher in the zuranolone clinical trials, hailed the approval as a crucial advancement in maternal mental health, providing a much-needed rapidly acting antidepressant option.
Concerns from Experts
- Some experts worry that the medication could be overprescribed and may not be the best first-line treatment for patients with mild to moderate postpartum depression.
- Catherine Monk, professor and chief of the division of women’s mental health in Obstetrics & Gynecology at Columbia University, stresses the importance of psychotherapy and other behavioral and lifestyle changes as initial responses for such patients.
While zuranolone's approval signifies a major step forward in addressing postpartum depression, experts urge caution in overreliance on medication and emphasize the value of comprehensive care for new mothers. The postpartum period is a vulnerable time, and the availability of this new treatment option could be a lifeline for many women in need. However, addressing underlying social determinants of health and offering psychotherapy and support remain critical components of combating this condition effectively.
