FDA approves drug for treating postpartum depression

FDA approves drug for treating postpartum depression

Shares of Sage Therapeutics (NASDAQ:SAGE) reached skyward early Wednesday based on news that the Food and Drug Administration approved the first postpartum depression drug called Zulresso.

The treatment's 60-hour length could make it hard for some new mothers to be able to participate ― after all, it involves sedation, and patients must be accompanied when interacting with their children during the infusion, according to the release.

It's also pricey, coming in at $34,000 per infusion - and costs even more after factoring in the two-day medical center stay.

The drug's trade name is Zulresso.

On social media, people expressed joy at the availability of treatment and dismay at the cost of the drug.

A pill version of the treatment could make the drug more widely accessible, and is now undergoing clinical trials, according to the Times.

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Manufacturer Sage Therapeutics told the Times it does expect insurance companies to cover the drug.

Zulresso is an IV injection used to treat the sometimes life-threatening condition of postpartum depression, which is a major depressive episode that occurs following or leading up to childbirth. Women may experience thoughts about harming themselves or harming their child. "Postpartum depression can also interfere with the maternal-infant bond", Dr. Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option".

Because of the drug's risks, including sudden loss of consciousness, Zulresso will only be available at certified health care facilities where patients can be carefully monitored, according to the press release. 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. And in both studies, the women given Zulresso showed a marked improvement compared to those on the placebo, the FDA said.

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.

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