The Food and Drug Administration (FDA) made an exciting announcement on Friday, granting approval for the first ever oral treatment for postpartum depression. Known as zuranolone, this innovative once-a-day pill will be marketed as Zurzuvae by its creators, Sage Therapeutics and Biogen.
Zuranolone has received FDA approval for use in adults to treat postpartum depression, a type of major depression that can occur after childbirth or during the later stages of pregnancy. It affects approximately 15% of women in the weeks or months following childbirth, often leading to extreme and potentially life-threatening emotions. Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, highlighted the significance of this oral medication as a beneficial option for women in such situations.
Prior to this approval, Sage Therapeutics’ brexanolone, marketed as Zulresso, was the only authorized option for treating postpartum depression. However, Zulresso must be administered intravenously via infusion. The FDA approved this therapy in 2019 as the first specifically designed treatment for postpartum depression.
Both Sage Therapeutics and Biogen believe that zuranolone, like brexanolone, acts as a steroid that binds to GABA receptors in the brain. This mechanism helps to reset neurotransmitters that have been disrupted in patients struggling with depression. The drug targets the brain networks responsible for mood, arousal, behavior, and cognition to help swiftly rebalance dysregulated neuronal networks and restore brain function.
Zuranolone’s label includes a boxed warning advising patients not to drive or operate machinery for 12 hours after taking the drug. Common side effects include drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infection. There is also a risk of suicidal thoughts, and the drug may cause fetal harm. Women taking zuranolone should use contraception, according to the FDA’s recommendations.
Sage Therapeutics and Biogen had promoted this once-daily pill as part of a potential new “paradigm” for the treatment of major depression. They had sought FDA approval for both postpartum depression and major depressive disorder. However, the FDA has only approved the drug for postpartum depression.
The drug now awaits clearance from the Drug Enforcement Agency, a process that typically takes 90 days, before it can be introduced to the market.
Please note that this story is still developing and will be updated accordingly.
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