First oral pill for postpartum depression approved by US FDA
The label carries a boxed warning indicating that Zurzuvae may impair driving and other hazardous activities.
New York: In a first, the US Food and Drug Administration (FDA) has approved an oral medication to treat postpartum depression (PPD) in adults.
Manufactured by Sage Therapeutics and Biogen, Zurzuvae (zuranolone) has been approved as a once-daily pill (50mg) to be taken for 14 days.
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PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. To date, treatment for PPD was only available as an IV injection given by a healthcare provider in certain health care facilities.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child,” said Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in a statement.
“And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,”Farchione said.
As with other forms of depression, PPD is characterised by sadness and/or loss of interest in activities that one 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 randomised, double-blind, placebo-controlled, multicenter studies.
In Study 1, patients received 50 mg of Zurzuvae or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product that was approximately equal to 40 mg of Zurzuvae or placebo, also for 14 days.
Patients in the Zurzuvae groups showed significantly more 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 labelling contains a boxed warning noting that Zurzuvae can impact a person’s ability to drive and perform other potentially hazardous activities.
The FDA warned that the most common side effects include drowsiness, dizziness, diarrhoea, fatigue, nasopharyngitis (the common cold), and urinary tract infection. The agency also warned that patients should not drive for at least 12 hours or operate heavy machinery after taking the pill.
