The U.S. Food and Drug Administration. ?FDA, for its acronym in English? approved Zurzuvae ?zuranolone?, the first oral medication for postpartum depression ?DPP? in adults.
Postpartum depression is a major depressive episode that usually occurs after childbirth, although it can also begin during the later stages of pregnancy.
Until now, treatment for DPP has only been available as an intravenous injection administered by a healthcare provider at certain healthcare facilities.
“Postpartum depression is a serious and life-threatening condition in which women experience sadness, guilt, worthlessness and even, in severe cases, thoughts of harming themselves or their children. And because it can disrupt the mother-infant bond, it can also have consequences for a child's physical and emotional development," said Tiffany R. Farchione, director of the Division of Psychiatry at the FDA's Center for Drug Evaluation and Research. .
"Having access to an oral medication will be a beneficial option for many of these women who are dealing with extreme and sometimes life-threatening feelings," she added.
As with other forms of depression, PPD is characterized by sadness and/or loss of interest in activities you used to enjoy and a decreased ability to feel pleasure. It can present with symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy, or suicidal ideation.
The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two multicenter, randomized, double-blind, placebo-controlled studies.
Trial participants were women with PPD who met 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 of delivery.
Patients in the Zurzuvae groups showed significantly greater improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at day 42, four weeks after the last dose of Zurzuvae.
The label contains a boxed warning stating that Zurzuvae can affect a person's ability to drive and perform other potentially dangerous activities, so patients should not engage in such activities for at least 12 hours after taking the medication.
The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis?common cold? and urinary tract infection.
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