Valencia (EP). The U.S. Food and Drug Administration (FDA) has approved “Zurzuvae” (zuranolone), the first oral medication for the treatment of postpartum depression in adults.
The FDA detailed in a statement that the recommended daily dose of “Zurzuvae” is 50 mg once daily for 14 days, taken in the evening with a fatty meal.
Postpartum depression is a severe depressive episode that usually occurs after childbirth, but can also begin during the final stages of pregnancy. Until now, treatment for postpartum depression was only available intravenously by healthcare professionals in 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 children. For many patients with postpartum depression, getting oral Drugs would be a beneficial option. The director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research said: Tiffany R. Facione.
Like other forms of depression, postpartum depression is characterized by sadness and/or loss of interest in activities once enjoyed, as well as a decreased ability to feel joy. You may experience symptoms such as cognitive decline, feelings of sadness or powerlessness, loss of energy, or suicidal ideation.
The efficacy of “Zurzuvae” in the treatment of postpartum depression in adults has been demonstrated in two randomized, double-blind, placebo-controlled multicenter studies. Participants in the trial were women who developed symptoms in the third trimester or within four weeks of giving birth.
In the first study, patients received either 50 mg of “Zurzuvae” or a placebo every night for 14 days. In Study 2, patients received either another zuranolone product approximately equivalent to 40 mg “Zurzuvae” or a placebo, also for 14 days.
Patients in both studies were followed for at least 4 weeks after 14 days of treatment. Patients in the “Zurzuvae” group experienced a significant improvement in symptoms compared to the placebo group. On day 42, four weeks after the last dose of “Zurzuvae”, the therapeutic effect was maintained.
The treatment package insert contains a boxed warning that “Zurzuvae” may affect a person’s ability to drive and perform other potentially hazardous activities. Therefore, 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 were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold), and urinary tract infection. In addition, women should use effective contraception during and for a week after taking “Zurzuvae”.