Capital | FDA approves first oral drug for postpartum depression

A serious, life-threatening condition that leaves women with feelings of sadness, guilt, and worthlessness




SILVER SPRING, MD — /PRNewswire-PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Zurzuvae (zuranolone), the first drug for the treatment of postpartum depression (DPP) in adult women Oral drugs. Postpartum depression is a severe form of depression that usually occurs after childbirth, but can also start later in pregnancy. Until now, PPD treatment could only be given intravenously by a healthcare provider at certain medical facilities.

“Postpartum depression is a serious and life-threatening condition in which women experience feelings of sadness, guilt, worthlessness and, in severe cases, thoughts of harming themselves or their baby. Because postpartum depression can disrupt the mother-baby relationship, it It can also have an impact on the baby’s physical and emotional development,” said Tiffany R. medication management. “Access to oral medications would be beneficial for the many women facing extreme and sometimes life-threatening sensations.”

Like other forms of depression, DPP is characterized by sadness or loss of interest in previously pleasurable activities and a decreased ability to feel pleasure. It may present with symptoms such as cognitive decline, feelings of sadness or powerlessness, loss of energy, or suicidal thoughts.

The efficacy of Zurzuvae for the treatment of PPD in adult women has been demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. Trial participants were women with postpartum depression who met the Diagnostic and Statistical Manual of Mental Disorders’ criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks after delivery. In Study 1, patients received Zurzuvae 50 mg or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product approximately equivalent to Zurzuvae 40 mg or placebo, also for 14 days. Patients in both studies were monitored for at least 4 weeks after 14 days of treatment. The primary endpoint for both studies was change in depressive symptoms, measured at day 15 using the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. Symptoms improved significantly in the Zurzuvae-treated group compared to the control group. Those in the group that received a placebo. On day 42, 4 weeks after the last dose of Zurzuvae, the therapeutic effect was maintained.

The label contains a boxed warning stating that Zurzuvae may interfere with a person’s ability to drive and perform other potentially hazardous activities. Patients may also not be able to assess the extent of their injury. To reduce the risk of injury, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.

The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold), and urinary tract infection. Using Zurzuvae may cause suicidal thoughts and behaviors. Zurzuvae can cause fetal harm. Women must use effective contraception while taking Zurzuvae and for one week after taking Zurzuvae.

The recommended daily dose of Zurzuvae is 50 mg. Take once daily for 14 days in the evening with a fatty meal.

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