Technology

FDA Grants Approval for First-Ever Pill To Tackle Postpartum Depression


The US Food and Drug Administration last week approved a pill for treating postpartum depression. The first oral treatment designed specifically for treating postpartum depression, Zurzuvae’s approval has been welcomed as a likely much cheaper, specific treatment for a condition that affects as many as one in seven people after they give birth.

Dr. Sarah Oreck, a reproductive psychiatrist who practices in California and New York, said that it’s exciting to see a medication target a mechanism that “underpins” postpartum depression in a way that traditional antidepressants can’t.

“There’s gonna be a lot of people that need this medication, and I’m hoping we can do whatever we can to make it widely accessible,” Oreck said. 

But despite being “incredibly excited” about a drug that’s proved to be fast-acting at treating PPD in clinical trials, Oreck says there’s still some “apprehension” over who’ll actually be able to use it. As of now, there’s no word on how much it’ll cost. The only other drug on the market specifically for treating postpartum depression is a $34,000 IV drip.

Here’s what to know about postpartum depression and Zurzuvae, the pill to treat it.

What is postpartum depression?

Postpartum depression is a condition that’s categorized by persistent feelings of sadness, worthlessness, and despair that interferes with daily tasks. In more severe cases, it can lead to suicide — which is one of the leading causes of maternal deaths that happen after birth.

PPD can affect anyone, but women with a history of a mood disorder like depression or mood changes associated with the menstrual cycle are at higher risk. Other factors like not having help with the new baby, having a difficult delivery a recent move or more stress can also increase the risk of PPD. It typically starts within the first three weeks of delivery, but can occur up to a year after having a baby, according to the American College of Obstetricians and Gynecologists. 

A milder form of depression, called the “baby blues,” may affect more than half of people after they deliver, though it typically subsides by itself within a couple of weeks.

While the symptoms of PPD can overlap with other forms of depression, there is a direct link between the dramatic drop of hormones that happens after someone gives birth and the onset of depression with PPD. A pill that better narrows in on the cause of PPD means more effective treatment, as has been shown in clinical trials

A woman holding a phone up in her bed while a baby sleeps nearby

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How effective is Zurzuvae and how does it work?

Zurzuvae is a pill that you take for two weeks, every day, in the evening with a “fatty meal,” per the FDA. In part, it’s thought to work because it contains a metabolite of progesterone (allopregnanolone), according to Oreck. Because progesterone and estrogen levels steeply drop after delivery, the medication may give the body a boost and help it compensate for that huge hormone drop.

“That’s a very simple idea of what the mechanism is,” Oreck said.

Compared to people who took a placebo, those who took Zurzuvae showed “significantly more improvement in their symptoms” when scored on a depression-rating scale at day 15, according to the FDA, and the effects lasted four weeks. Some results on Zurzuvae were published in the American Journal of Psychiatry. 

“It’s very exciting for a medication, also, to be taken for 14 days — that’s, like, revolutionary,” she said. Most medications for mood have to be taken on a daily basis, and effects typically take longer to kick in.

Read more: Best Mental Health Apps to Start Using Today 

Who may be a good candidate for Zurzuvae 

The drug is approved for adults with PPD, which is a major depressive episode.

Because people who were breastfeeding were excluded from the trial, there’s no information on how it’ll affect breastmilk. This means that people who wish to breastfeed will likely be advised to stop during the two weeks they take Zurzuvae. 

“For someone with severe depression, the trade-off of not breastfeeding for two weeks is something that you could probably make,” Oreck said. For someone with milder symptoms who doesn’t want to disrupt their supply, she said, the decision on whether to start a medication will be more nuanced. 

You also can’t take the pill if you’re pregnant, as Zurzuvae could affect the fetus, according to the FDA. 

Similar to other medications, you shouldn’t drive or operate heavy machinery for 12 hours after the pill. The FDA added a “black box warning,” which it reserves for side effects with a higher risk, about the risk of driving or engaging in something else that could be dangerous for those 12 hours after you take the pill.

Despite promising reuslts, Oreck says it’s important not to view this as a “magic pill.” 

“We have to be apprehensive about saying, ‘you just need this medication and that’s it,'” Oreck said. In addition to medication, support systems, therapy, and ways that address the costs associated with becoming a mother and contribute to the risk of PPD “have to be in place.”

“It’s not a magical pill — it’s not gonna make all of these stressors go away.” 

Read more: Best Online Psychiatry Services in 2023 

When new parents can get it and how much it’ll cost 

The pill is expected to be available in the last three months of 2023, according to manufacturer Sage Therapeutics. There’s no estimate on how much it’ll cost yet, and the drugmaker didn’t immediately respond for a request for comment on the price. 

However, it is expected to be cheaper (and way more available to people) than the only other treatment designed specifically for PPD — an IV treatment called Brexanolone that needs to be given in a hospital over a period of 60 hours and costs over $30,000. Per the Mayo Clinic, Brexanolone works by slowing the rapid drop of hormones following birth.

Other treatment options for postpartum depression

Besides Brexanolone, people with postpartum depression may be offered more traditional treatments for depression, including talk therapy or other medication.

You may also ask your midwife or Ob-Gyn about finding a support group, online or in-person, to meet with other parents who are experiencing PPD. This may be especially important if there are other stressors that may be contributing to your postpartum depression, besides the physical and hormonal changes that come with childbirth. 

Read more: Top Signs You Might Have Depression, and How to Get Help and Perinatal Depression: What It Is and How to Cope