Brainstorm Health: Sage Postpartum Drug, Gilead Price Hikes, Peloton Suit

FDA Approves First Drug Targeted At Treating Postpartum Depression

The U.S. Food and Drug Administration announced Tuesday the approval of the first drug specifically created to treat postpartum depression in new mothers.

Although the new drug reportedly has no long-term negative side effects, it's not approved for women who are breastfeeding and is a sucker punch to the wallet.

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.

In clinical trials sponsored by Sage Therapeutics Inc., the company that makes the drug, brexanolone injections resulted in "significant" improvements in mothers with moderate or severe postpartum depression. One intravenous session will cost families anywhere between $20,000 to $35,000, though it's unclear what insurance companies will cover. "We have had the same treatments for depression for 30 years". But Zulresso's manufacturer, Sage Therapeutics, expects the drug to be covered under insurance. "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.

A pill form of the drug is now going through clinical trials, which would make Zulresso more widely available to patients unable to be admitted for an extended inpatient treatment as required when taken in the IV form.

Doctors say it is much faster and more effective than the standard antidepressants generally given to women suffering depression in the year after giving birth.

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"This approval marks the first time a drug has been specifically approved to treat post-partum depression, providing an important new treatment option", she added. And the condition impacts 1 in 9 women nationally, according to the Centers for Disease Control and Prevention.

Zulresso will only be available through a restricted program because of concerns about risks including excessive sedation or sudden loss of consciousness during administration.

Brexanolone is synthetic form of allopregnanolone, which is a hormone produced by progesterone in the brain that can help alleviate depression, Dr. Samantha Meltzer-Brody, who led the clinical studies, told the Times.

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".

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. "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.

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