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FDA Approves First-Ever Postpartum Depression Drug

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Breaking news for moms-to-be: The US Food and Drug Administration (FDA) has approved a drug that specifically targets postpartum depression (PPD). The drug, called Zulresso, is the first ever FDA-approved medication to treat PPD, which affects one in nine new mothers.

Zulresso (brexanolone) is an intravenous infusion given continuously over 60 hours (2.5 days). Clinical trials have shown that it treats PPD symptoms within hours of infusion, and the positive effects were still observed 30 days later.

The new treatment option can be seen as a medical breakthrough for women’s mental health – because as any sufferer knows, PPD isn’t something to be taken lightly.

"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 Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a press announcement on March 19. 2019.

Common side effects of Zulresso include sleepiness, flushing, and dry mouth – although more severe risks also exist. "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," says Dr. Farchione.

Zulresso has a scheduled release date of late June, according to developer Sage Therapeutics. The biopharmaceutical company says the drug will likely cost $7,450 per vial for a total price of $20,000 to $35,000.

The steep price tag will likely turn off some mothers – and so might the 60-hour time commitment. Zulresso could also interfere with breastfeeding, and patients should discuss nursing with their healthcare provider before taking the drug. Despite the downsides, however, Zulresso provides hope for both mothers and physicians.

Treating Postpartum Depression in Pregnancy

One in nine women experience postpartum depression during pregnancy and/or after childbirth. That equates to around 400,000 new mothers each year. Unlike the short-lasting “baby blues,” PPD sticks around longer than two weeks.

Symptoms of PPD include sadness, loss of enjoyment in activities that previously sparked happiness, feelings of guilt and worthlessness, appetite changes, hopelessness, low energy, problems with concentration, and negative feelings toward your new baby. In severe cases, a new mother may suffer from suicidal thoughts. Symptoms can last for weeks or years.

To treat PPD, women usually attend counseling or therapy. They might also take antidepressants like selective serotonin reuptake inhibitors. But these medications don’t usually provide relief within hours, as Zulresso has been shown to do in clinical trials.

So how does Zulresso differ traditional antidepressants? In part, it contains a synthetic form of allopregnanolone, a neurosteroid that exists in the body throughout pregnancy and naturally decreases after a woman gives birth. Zulresso can help regulate allopregnanolone after birth, which experts believe will ward off PPD.

When testing Zulresso, two phase III trials involving more than 200 women with PPD symptoms took place in 2016 and 2017. “One study included patients with severe PPD and the other included patients with moderate PPD,” according to the FDA press release. “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, Zulresso 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."

Zulresso aims to reduce the number of PPD cases in new mothers in years to come. Also, discussions about PPD will hopefully eliminate the stigma involved with a diagnosis, and let mothers know it's normal to feel sad or depressed after giving birth.

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