US OKs drug for post-partum depression

A new baby holdS the finger of its mother on Jan. 23 2016

It has been approved by the Food and Drug Administration (FDA).

On Tuesday, the FDA announced it had signed off on allowing the drug called brexanolone (marketed as Zulresso) to be administered intravenously to patients over a period of 60 hours. The news release said clinical trials, which involved more than 200 women, showed brexanolone worked within hours to help treat postpartum depression, which affects 1 in 9 new mothers. One intravenous session will cost families anywhere between $20,000 to $35,000, though it's unclear what insurance companies will cover. "It may be worth it if somebody has been treatment-resistant or they can't wait the two to four weeks for an antidepressant to kick in".

U.S. media say the treatment will cost $34,000 a year for people without health insurance.

Also, Sage Therapeutics advised that patients talk to their doctor about breastfeeding because the drug will pass into breast milk.

Another pill, now involved in clinical trials, has also shown positive results and could be submitted for FDA approval in a couple of years, Sage Therapeutics told The New York Times.

Estimates indicate that each year, more than 400,000 infants in the United States are born to mothers who are depressed, CNN reported.

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The Centers for Disease Control and Prevention say 11.5 per cent of new mothers suffered from post-partum depression in 2012. In serious cases, some women experience suicidal thoughts. "This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option".

The FDA's announcement of Zulresso's approval makes it clear that patients must be strictly monitored during the treatment "because of the risk of serious harm due to sudden loss of consciousness". Treatment options traditionally include psychotherapy and antidepressants, according to the Mayo Clinic.

Researchers evaluated the drug in two clinical studies - one with women with severe PPD, and the other on women with moderate PPD. In trials, women said they felt marked improvement within 24 hours. The hormone increases throughout a woman's pregnancy and plummets after she gives birth, potentially contributing to depressive symptoms.

"Women who had not wanted to eat or interact with others suddenly were smiling, interacting, becoming more social", Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina's Center for Women's Mood Disorders, told CTV News.

But she said the treatment is "unlike anything else that we have available" and that the data collected in clinical trials so far has been "compelling". "There's an enormous need for new, novel ways to treat depression, and to treat it quickly". The pill, now known as SAGE-217, is produced from a comparable molecule to the particle used in Zulresso, the Times said. "It does women a service because it really brings attention to a major medical problem and provides legitimacy, and hopefully will encourage people, whether they use this medication or not, to seek and obtain treatment", she said.

"People need to reach out and get screened and get treatment", she added, "regardless of if treatment is with brexanolone or not".



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