The FDA Approves the First Postpartum Depression Pill in the US
The future is bright for women with postpartum depression, as the new drug could transform the treatment for the mental disorder (Yuris Alhumaydy/Unsplash).
The future of patients' outcomes with postpartum depression is very promising, after seeing evidence of effectiveness from clinical trials of zuranolone, a new pill to treat the mental disorder.
Article by Isabel Cantor, Associate Medical Reporter
SILVER SPRING, Md. - Postpartum depression is a mental illness that affects one in every seven women that have just given birth in the United States, therefore making cases very common throughout the nation. Being diagnosed with the disorder is potentially very serious. Luckily, the US Food and Drug Administration (FDA) has recently approved the drug zuranolone (which will be sold under the brand name Zurzuvae) on Friday, August 4, to treat postpartum depression.
"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," said Dr. Tiffany R. Farchione, director of the Division of Psychiatry at the FDA's Center for Drug Evaluation and Research, in a statement.
It is essential that women diagnosed with postpartum depression get the treatment and medical attention that fits the severity of their symptoms.
“[Postpartum depression] is often underdiagnosed and undertreated. With the FDA’s decision today, we may be able to reverse this and help many more women in need,” Dr. Kristina Deligiannidis said, a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in New York who has been heavily involved in clinical trials of zuranolone.
Zuranolone is a once-daily pill, taken over the course of 14 days. The recommended dose is 50 milligrams, and the pill should be taken in the evening with a fatty meal. In addition, users of the drug should not “drive or operate heavy machinery” for at least 12 hours after taking the pill, according to the FDA.
Aside from the wide variety of treatments that are currently used by many women suffering from postpartum depression, such as antidepressants, anti-anxiety medications, and psychotherapies, there has not been an oral pill available tailored specifically for the treatment of postpartum depression.
Zulresso, the first treatment specifically for postpartum depression, was approved by the FDA in 2019. It is administered differently than zuranolone, but it works very similarly. Zulresso is administered through an IV infusion, and it is only administered in a healthcare setting. On the other hand, zuranolone is taken orally, at the user’s convenience. Also, Zulresso can cost up to $35,000 per treatment. As of now, zuranolone seems more convenient, but until the price is released, we can’t know which treatment will be more favorable by the general public.
There have been various clinical trials to test the effectiveness of zuranolone, and the results look promising. Symptom relief was shown in as little as 3 days after starting the drug.
ABC News Medical Contributor, Dr. Darien Sutton, stated in an interview that he predicts the drug will be available for use towards the end of 2023. Since the FDA has very recently approved zuranolone, it now has to be reviewed by the Drug Enforcement Administration for 90 days before the drug can officially be released.
However, accessibility is the next big question as the official release of zuranolone is approaching. Cost is a major factor that can sway people away from taking the drug, but Sage Therapeutics and Biogen, the makers of the drug, have not yet announced the price.
Another concern about the release of zuranolone is that “this medication will just get used for everybody. Whereas for people with mild to moderate depression, the gold standard of care is to start with psychotherapy and other behavioral and lifestyle changes,” said Catherine Monk, a professor and chief of the division of women’s mental health in Obstetrics & Gynecology at Columbia University Vagelos College of Physicians and Surgeons. Since the pill was originally intended for and tested on patients with severe cases of postpartum depression, people with mild cases should not immediately jump into using the drug.
Although there are some concerns that come with the release of zuranolone, the future is bright for women with postpartum depression, as the new drug could transform the treatment for the mental disorder.