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Silver Spring, Maryland, August 8, 2023 /PRNewswire-PRNewswire/Spain/ — The U.S. Food and Drug Administration (FDA) has approved Zurzuvae (zuranolone), the first oral medication for the treatment of postpartum depression (PPD) in adult women. 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 relationship between mother and baby, it can also It can have an impact on the baby’s physical and emotional development.” Tiffany R. FacioneDirector, Division of Psychiatry, FDA Center for Drug Evaluation and Research. “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 of both studies was change in depressive symptoms scored using the Total Depression Rating Scale. hamilton 17-item depression assessment (HAMD-17) measured on day 15. Patients in the Zurzuvae group experienced significant improvement in symptoms compared to the placebo group. 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.
FDA granted the application Priority Review and Expedited Review Program designations.
Sage Therapeutics, Inc. received Zurzuvae approval.
FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the protection, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products intended for human use. medical equipment. The agency is also responsible for the protection and safety of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
Media Information: Gloria Sánchez-Contreras, 301-796-7686, gloria.sanchez-contreras@fda.hhs.gov
Consumer Information: 888-INFO-FDA
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Source: U.S. Food and Drug Administration