Landmark Drug Treats Postpartum Depression

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With the green light from the U.S.Food and Drug Administration (FDA), Zulresso is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth.

Clinical trials showed that the drug improved women's postpartum depression for at least 30 days after the infusion, the FDA said.

Zulresso has been approved with a Risk Evaluation and Mitigation Strategy program, 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, he said.

Psychiatrist Dr. Martha Wald agreed that women battling postpartum depression have long needed new options.

Sage submitted its New Drug Application in May 2018 based on data from two Phase III clinical trials in patients with severe postpartum depression and moderate postpartum depression.

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"Due to possibly needing to separate the mother and child, this would likely not be a first-line drug for postpartum depression", Wu said. But Zulresso's manufacturer, Sage Therapeutics, expects the drug to be covered under insurance. "Women may experience thoughts about harming themselves or harming their child, as well as hinder development of a maternal-infant bond", the press release reads. Yet some women may face barriers accessing this type of treatment, as it requires 60 hours of time. She treats them with anti-depressants, because that's what is available.

While the cost of Zulresso may be out of reach for many patients, it goes into effect in hours as opposed to current antidepressants used to treat PPD - which can take weeks to kick in, if at all. After childbirth, "most" new mothers experience a range of symptoms, including mood swings, crying, trouble sleeping and irritability. Eligible trial participants included women age 18-45 years old who were six months postpartum or less at screening and had onset of symptoms during pregnancy or within 4 weeks of delivery.

Dr Karp said he's concerned that the drug infusion is a reactionary measure for a problem professionals should be trying to prevent as the first port of call.

"We are proud to be a part of this important moment in mental health, creating the opportunity for an unprecedented change in the way PPD is thought about and treated moving forward", Jeff Jonas, MD, CEO of Sage, said in the company's release. Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill, the principal investigator of the brexanolone studies explained that this hormone can reduce the symptoms of anxiety and depression in the brain of the patient with postpartum depression.

The treatment is also expensive; it can cost between $20,000 and $35,000, not including the cost of the hospital stay. Other side effects may include sleepiness, dry mouth and flushing.

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