The Food and Drug Administration on Friday approved the first pill to treat postpartum depression. Clinicians could begin prescribing zuranolone to women as soon as November.
In the drug’s clinical trial, whose findings were published July 26, zuranolone was shown to be safe and effective while significantly improving depression symptoms in new mothers. The fast-acting, once-daily pill can be used to treat both major depressive disorder and postpartum depression, which affects 13% of women.
“When moms are depressed, they tend not to interact with their children in the same way as they would if they were not depressed,” said Jennifer Payne, a University of Virginia Health psychiatrist, said at a UVa Health briefing Friday. Payne, who specializes in caring for women with postpartum depression, said it can affect a baby’s IQ and language development.
“It’s important to quickly and effectively treat postpartum depression, and this new drug alone is going to be a great tool to help us do that,” she said.
Zuranolon is an oral version of a drug approved in 2019 to treat postpartum depression called brexanolone. Brexanolone can only be administered by IV, which requires a patient stay in hospital and continuous monitoring over the three-day treatment.
Standard antidepressants also work to treat postpartum depression, but with a 50% response rate “at best,” Payne said.
The low-barrier zuranolon, on the other hand, has a 78% response rate, Payne said. It can alleviate symptoms in as few as three days and only takes 14 days for a sustained response to the drug. That’s important for women who want to return to breastfeeding quickly, she added.
Zuranolon is a synthetic version of allopregnanolone, a metabolite of progesterone. During pregnancy, levels of allopregnanolone rise, then plummet during postpartum. Especially in women genetically predisposed to postpartum depression, the drop in hormones can cause symptoms such as an inability to sleep, a lapse in hygiene and self-care, feelings of hopelessness and in some cases suicidal ideation or thoughts of harming the baby.
Zuranolon acts on the receptors in the brain, which works to calm and “reset” the brain into a more normal pattern of activity, relieving symptoms, Payne said.
“The idea with these drugs is to replace the levels of allopregnanolone at least temporarily, which helps reset the brain into a neutral mood as opposed to a depressed mood,” Payne said.
Zuranolon was also approved Friday to treat major depressive disorder.
“This brings online a whole new way for treating depression in general,” Payne said.
Still, there is more research to be done, such as how to treat women who don’t respond to zuranolon. Payne pointed out other ways the drug could be studied in future clinical trials, such as in patients with bipolar disorder, anxiety disorders and post-traumatic stress disorder.
Even with a better treatment option, postpartum depression is hard to identify, remaining undiagnosed in more than 50% of women with the condition, Payne said. That’s due to limited resources for perinatal mental health care, as well as stigma associated with postpartum depression.
“There’s a real stigma about feeling depressed when you’ve had a happy event like having a new child,” Payne said. “Many women feel so guilty that they will not admit that they are having trouble and struggling with postpartum depression.”
Payne’s research has included developing biomarkers of the condition that, when identified during pregnancy, help predict a woman’s risk for postpartum depression. Based on that risk, Payne said clinicians could take preventative measures postpartum instead of treating the condition reactively.
“In a drug like this [zuranolon], something that I’m interested in is looking at prevention of postpartum depression,” Payne said.
Source: www.dailyprogress.com
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