USALife.info / NEWS / 2023 / 08 / 04 / FDA APPROVES FIRST PILL FOR POSTPARTUM DEPRESSION, OFFERING NEW TREATMENT OPTION
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FDA Approves First Pill for Postpartum Depression, Offering New Treatment Option

22:45 04.08.2023

Federal health officials have granted approval for the first pill specifically designed to treat severe depression after childbirth. The pill, called Zurzuvae, is intended for adults experiencing severe depression related to childbirth or pregnancy. It is taken once a day for 14 days. The Food and Drug Administration (FDA) made the decision after reviewing two studies conducted by Sage Therapeutics, the company behind Zurzuvae.

Postpartum depression affects an estimated 400,000 individuals each year in the United States. While the condition often resolves on its own within a few weeks, it can persist for months or even years in some cases. The standard treatment options for postpartum depression include counseling and antidepressants, but these can take weeks to take effect and are not effective for everyone.

Dr. Tiffany Farchione, the FDA's director of psychiatric drugs, stated that having access to an oral medication like Zurzuvae will be beneficial for many women experiencing extreme and potentially life-threatening feelings. The approval of the pill is based on the positive outcomes observed in the company's studies. Women who took Zurzuvae showed fewer signs of depression over a four- to six-week period compared to those who received a placebo. The benefits were evident within three days for many patients, as measured by a psychiatric test.

One participant in the study, Sahar McMahon, shared her experience with postpartum depression after the birth of her second daughter in late 2021. McMahon, who resides in New York City, had never experienced depression before and found herself no longer wanting to spend time with her children. She enrolled in the study and noticed a significant improvement in her mood and outlook within days of taking the first pills. McMahon described the transition as waking up and feeling like herself again.

Dr. Kimberly Yonkers, a psychiatrist specializing in postpartum depression at Yale University, praised the effectiveness of Zurzuvae, stating that the drug is likely to be prescribed to women who have not responded well to antidepressants. However, she expressed concerns about the lack of long-term data on how patients fare beyond the initial 45-day period. Yonkers emphasized the importance of understanding whether individuals maintain their well-being or experience relapses.

Sage Therapeutics, the manufacturer of Zurzuvae, has not yet announced the pricing for the pill. The company's previous drug, a similar infused version administered intravenously over three days, received FDA approval in 2019 but is not widely used due to its high price tag of $34,000 and logistical challenges. The pill form of Zurzuvae is reported to have milder side effects compared to the intravenous version, with drowsiness and dizziness being the most common. The pricing of the pill will play a crucial role in determining its accessibility and prescription rates.

/ Friday, August 4, 2023, 10:45 PM /

themes:  New York City  New York (state)

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