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Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDAâ€™s Center for Drug Evaluation and Research, said in a prepared statement that the approval provides an important new treatment option for PPD.
Officials with the FDA have approved brexanolone (Zulresso, Sage Therapeutics) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement that the approval provides an important new treatment option for PPD.
"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond," said Farchione.
PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.1
The efficacy of brexanolone was shown in 2 clinical studies in participants who received a 60-hour continuous intravenous infusion of the drug or placebo and were then followed for 4 weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo controlled studies, brexanolone demonstrated superiority to placebo in improvement of 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 adverse reactions reported by patients treated with brexanolone in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing this therapy in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors.
"Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient," said Farchione.
The REMS requires that patients be enrolled in the program prior to administration of the drug. Brexanolone is administered as a continuous IV infusion over a total of 60 hours (2.5 days). Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous monitoring of oxygen levels in the blood. While receiving the infusion, patients must be accompanied during interactions with their child(ren).
The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information. Patients will be counseled on the risks of brexanolone treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion.
The FDA previously granted Sage’s application for brexanolone injection Priority Review and Breakthrough Therapy designations. This therapy is expected to become available in late June.
“We are proud to be a part of this important moment in mental health, creating the opportunity for an unprecedented change in the way postpartum depression is thought about and treated moving forward,” said Jeff Jonas, MD, chief executive officer of Sage, in a prepared statement.
“Not only do we believe Zulresso will address an important need for women’s mental health, the impact of PPD is multigenerational, and we look forward to bringing Zulresso to patients in urgent need of a new treatment option. We believe Zulresso will be a catalyst in starting a new dialogue emphasizing the importance of women’s mental health, and the importance of diagnosing and treating PPD.”