This is huge: FDA approves new drug for postpartum depression

The hormones surging through your body. The milk leaking through your shirt. The sleep deprivation. There are so many physiological factors that make postpartum depression (PPD) different than other types of depression, but the treatments are still the same, and unfortunately, they’re slow. Traditional selective serotonin reuptake inhibitors (SSRIs) can take weeks to start working, and for new mothers who are being crushed by PPD, that might as well be a century.

But this week the FDA approved a new treatment for PPD, an intravenous treatment that can have mothers feeling better within just 24 hours.

The good news is this drug can give a mother back all the joy and meaning and hope that PPD can steal within 24 hours.

The bad news is it costs $20,000 to $35,000 per treatment and at that price will be out of reach for most mothers who need it.

It’s called brexanolone, (although the manufacturer, Sage Therapeutics, plans is marketing the drug under the brand name Zulresso) and it treats PPD by treating hormonal changes, specifically those related to allopregnanolone, a metabolite of progesterone.

Allopregnanolone has been called the “anti-anxiety” hormone, and studies have linked lower levels of allopregnanolone in pregnancy to an increased risk for PPD. Typically, women’s allopregnanolone levels are highest in the third trimester, but after you give birth the levels go down quick, and it’s believed that crash is what causes some women to sink into depression.

Brexanolone, which is administered intravenously, is a formulation of allopregnanolone, and trials of the drug were extremely promising.

An initial proof-of-concept study led by perinatal psychiatrist Dr. Samantha Meltzer-Brody saw four women with severe PPD given an infusion of the drug over 60 hours. They all felt better in fewer than 24 hours.

“The first patient we infused was someone who was extremely depressed, had lost 20 pounds in a short period of time postpartum because she wasn’t eating at all, was very sad, didn’t want to interact with the baby — didn’t want to interact with anyone — and the family was extremely concerned,” Meltzer-Brody told The Huffington Post. “Twenty four hours after the infusion, she came out of her room, was smiling, ate her whole lunch, was talking to everyone. It was dramatic.”

Larger studies followed the first, and on Tuesday Dr. Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, announced the FDA approved the drug as the first treatment for postpartum depression.

“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. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” Farchione said in a press release.

As CNN reports, some mothers who have struggled with PPD, like Stephanie Hathaway, found nearly instant relief thanks to brexanolone trials.

“It was a 60-hour infusion and in the first 12 to 18 hours I felt the biggest difference,” the mom of two explains. “Those intrusive thoughts that played on repeat in my head, those went away and didn’t come back.”

It’s estimated that 400,000 babies are born to depressed mothers in America every year. This drug could be a game changer for women and their families if the cost is lowered.

Within a few months, the treatment will available through something the FDA calls the Zulresso Risk Evaluation and Mitigation Strategy (REMS) Program, which requires the drug be administered by a health care provider in a certified health care facility, but someday we could see wider use and hopefully, insurance coverage.

[Correction, March 20: An earlier version of this post stated this treatment is currently available through the Zulresso Risk Evaluation and Mitigation Strategy (REMS) Program. The treatment will not be available through that program until June 2019 at the earliest.]

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• Postpartum depression and anxiety are more common than you may think—here are the resources you need
• Finally: Pediatricians urged to screen new moms for perinatal depression
• To the mama battling postpartum depression: You are stronger than you realize