Postpartum Depression affects 1 in 7 women, while 10% of men also face prenatal and postpartum depression[1][2]. Amid the childbearing journey, perinatal mental health (PMH) disorders emerge as primary challenges, outranking other complications. These disorders include more than postpartum depression alone, spanning anxiety, obsessive-compulsive disorder, PTSD, bipolar disorder, and psychosis.
Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, exclaimed, “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.”[3] Postpartum depression (PPD) can stem from factors like genetics and hormonal changes after childbirth. Identified risk factors entail a history of physical or sexual abuse, diabetes, pregnancy complications, and additional life stressors such as coping with grief, illness, unemployment, or financial constraints.
To address the distress, on 4th August, the Food and Drug Administration (FDA) approved the first pill designed to treat postpartum depression. Sage Therapeutics and Biogen Inc. have come together to announce that their new drug, Zurzuvae (zuranolone), is expected to hit the market commercially in the fourth quarter of this year, possibly as early as October.
This pill, requiring only one daily dose for a period of 14 days, has shown promising results in two studies conducted by the manufacturers. Some patients have reported experiencing positive effects after three days of use. This rapid response time distinguishes it from other antidepressants and presents a more appealing option than the existing PPD drug brexanalone, marketed as Zulresso by Sage Therapeutics. Unlike Zulresso, which is administered intravenously and demands a 60-hour treatment period spanning approximately 2 and a half days, this new pill offers a simpler and more convenient approach.
Adding on the same, Tiffany R. Farchione said, “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings”[3].
Dr. Samantha Meltzer-Brody, leading Zurzuvae trials, explained that Zurzuvae contains synthetic allopregnanolone, a mood-regulating neurosteroid. Estrogen and progesterone experience a substantial increase before sharply declining during childbirth. Because of the hormone changes, the pill is unsafe to use until after childbirth. The pill hasn’t been studied for safety during pregnancy and could potentially harm the baby’s development. It’s also untested for breastfeeding effects[4].
Frequent side effects comprise tiredness, dizziness, diarrhea, weariness, common cold, and urinary tract infection. The label prominently warns that Zurzuvae can affect driving and other risky tasks, potentially without the person realizing their impairment. To enhance safety, patients should avoid driving or using machinery for at least 12 hours after taking Zurzuvae; therefore, it is recommended to be taken 50 mg once every day for 14 days, preferably in the evening.
Currently, the cost of the drug remains undisclosed. However, compared to other options, the treatment is expected to be more accessible to needy patients. For patients in the US with a dearth of psychiatrists, the pill is designed to serve as a viable treatment avenue for non-psychiatric prescribers or obstetricians aiming to assist their patients.
Note: As of now, this postpartum depression pill is announced to be available in the US only.
(The article is written by Dr.Subita Alagh, Senior Executive, and reviewed by Monalisa Deka, Senior Health Content Editor)
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