Federal health officials have given the green light to the first pill designed specifically to treat severe depression after childbirth, a condition affecting thousands of new mothers in the US annually. Known as Zurzuvae, the drug has gained approval from the United States Food and Drug Administration (USFDA) for use in adults experiencing severe postpartum or pregnancy-related depression. Taken once daily for 14 days, this oral medication offers a beneficial option for women coping with extreme and potentially life-threatening feelings during the postpartum period.
Dr Tiffany Farchione, FDA’s director of psychiatric drugs, expressed the significance of this approval, stating, “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
Postpartum depression affects an estimated four lakh people each year, and while it often subsides within a couple of weeks, some cases persist for months or even years. Standard treatments like counseling or antidepressants may take weeks to show results and do not work for everyone.
The Zurzuvae pill, developed by Sage Therapeutics, is an alternative to their existing infused drug administered intravenously over three days in a medical facility. Although the infused drug was approved by the FDA in 2019, its high cost of USD 34,000 and logistical challenges limited its usage.
The FDA’s approval of the pill is based on two studies conducted by the company, which demonstrated that women who took Zurzuvae experienced reduced signs of depression over a four-to-six-week period compared to those who received a placebo. The positive effects appeared within three days for many patients, as measured through a psychiatric test.
One study participant, Sahar McMahon, shared her experience, saying, “It was a quick transition for me just waking up and starting to feel like myself again.”
However, Dr Kimberly Yonkers of Yale University, a postpartum depression specialist, emphasized the importance of more follow-up data on how women fare after additional months, as there is limited information beyond 45 days.
Regarding pricing, Sage has not disclosed the cost of the pill yet, which may impact its prescription rate. The side effects of the new drug are milder than the IV version, including drowsiness and dizziness, and it was co-developed with Massachusetts-based pharmaceutical company Biogen.
Both the pill and IV forms mimic a derivative of progesterone, a naturally occurring female hormone necessary for maintaining a pregnancy. These drugs belong to the emerging class of medications called neurosteroids, which stimulate a different brain pathway than older antidepressants targeting serotonin, a chemical linked to mood and emotions.
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