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SPRING MONEY, Md., March 19, 2019 / PRNewswire / – The US Food and Drug Administration today approved the injection of Zulresso (brexanolone) for intravenous (IV) use in the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
"Postpartum depression is a serious illness that, when it is severe, can be life threatening. Women may have the idea of hurting themselves or their child. Postpartum depression may also interfere with the relationship between mother and infant. This approval marks the first time that a drug is specifically approved to treat postpartum depression, thus offering a new important treatment option., "I said Tiffany Farchione, M.D., Acting Director of the Division of Psychiatry Products in the FDA's Drug Evaluation and Research Center. "Due to concerns about serious risks, including excessive sedation or sudden loss of consciousness during the course of administration, Zulresso has been approved with a strategy of badessment and mitigation. the health care provider can carefully monitor the patient. "
DPP is a major depressive episode that occurs after childbirth, although symptoms may appear during pregnancy. As with other forms of depression, it is characterized by sadness and / or loss of interest in the activities that we previously appreciated and a decrease in the ability to feel pleasure (anhedonia) and may present symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.
Zulresso will only be available through a restricted program called the Zulresso REMS program that requires the drug to be administered by a health care provider in a licensed health facility. The REMS requires that patients be enrolled in the program prior to the administration of the drug. Zulresso is given as a continuous intravenous infusion over a total of 60 hours (2.5 days). Due to the risk of serious harm related to sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and benefit from continuous monitoring by pulse oximetry (control of the oxygen level in the blood). During the infusion, patients must be accompanied during interactions with their children. The need for these steps is addressed in a warning box in the prescription information of the drug. Patients will be informed of the risks badociated with Zulresso treatment and will be informed that these effects should be monitored in a health facility during the 60 hours of the infusion. Patients should not drive, use machinery or perform other hazardous activities as long as the feeling of sleepiness caused by the treatment has not completely disappeared.
The effectiveness of Zulresso has been demonstrated in two clinical studies in participants receiving continuous intravenous infusion of Zulresso or placebo for 60 hours and then followed for four weeks. One study included patients with severe PPD and the other with moderate PPD. The main measure in the study was the mean change from baseline depressive symptoms as measured by a depression rating scale. In the two placebo-controlled studies, Zulresso demonstrated superiority over placebo in improving depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.
The most common side effects reported by patients treated with Zulresso in clinical trials are drowsiness, dry mouth, unconsciousness, and hot flashes. Healthcare providers should consider modifying the treatment regimen, including stopping Zulresso in patients whose PPD worsens or who have emerging suicidal thoughts and behaviors.
The FDA has granted this application the status of priority review and innovative therapy.
Zulresso's approval was granted to Sage Therapeutics, Inc.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.
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SOURCE US Food and Drug Administration
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