What to know about Zurzuvae, the new pill for PPD

The recent approval of Zurzuvae (zuranolone)—the first oral medication indicated to treat postpartum depression (PPD)—marks a milestone. Now people can get targeted PPD treatment at home, and the fast-acting medicine is shown to have positive effects in as little as three days.

Zurzuvae “is going to be a game changer for treating maternal depression,” Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill, told The Washington Post last week. 

“I think [primary care providers are] going to feel more comfortable, that it’s just like treating a UTI or a sinus infection, and think, ‘I can do that.’” Craig Chepke, medical director of Excel Psychiatric Associates in Huntersville, N.C., told Fortune. (Chepke is a consultant for the medication’s co-developer Sage Therapeutics.) 

Like other types of depression, PPD causes loss of interest in activities once enjoyed, feelings of sadness, guilt and worthlessness, as well as a reduced ability to feel pleasure. It can come with fatigue, cognitive impairment and may disrupt the maternal-infant bond. In severe cases, PPD can come with thoughts of harming oneself or one’s child, along with suicidal ideation.

PPD is considered a perinatal mental health (PMH) condition, which also includes anxiety, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder, and substance use disorders. Together, these perinatal mental health conditions impact 1 in 5 pregnant or postpartum people (800,000 individuals) each year in the U.S., states the Maternal Mental Health Leadership Alliance.

Experts say that though the approval of zuranolone brings huge potential for reducing symptoms and improving quality of life for hundreds of thousands of women each year, we still need to work to reduce the stigma and support maternal mental health support on a broad scale.

Is Zurzuvae right for you?

The medicine is expected to launch during the fourth quarter this year. 

Zurzuvae can improve symptoms in as little as three days. Technically, it’s a neuroactive steroid that works on GABA-A receptors. (Lower levels of GABA are linked to depression.) Zurzuvae comes in 20 mg, 25 mg, and 30 mg capsules. Sage Therapeutics and Biogen make the drug, which is intended for more severe forms of PPD. 

Here are a few things to know about taking Zurzuvae:

• Zurzuvae should be taken in the evening with a meal that contains fat
• You can take it with other oral antidepressants, but there can be interactions—so check with your doctor
• The recommended dose is 50 mg daily for 14 days (ask your doctor for your ideal dose)
• It can affect how you drive, because it affects your central nervous system. Don’t drive until 12 hours after taking it
• Zurzuvae is a controlled substance, which means it’s regulated according to special standards. The drug will likely be put in the category that has low potential for abuse
• Talk to your doctor immediately if you have suicidal thoughts or behaviors while taking the medication.

The most common side effects of zuranolone are dizziness, diarrhea, fatigue, inflamed nasal passages, and urinary tract infection. Good news: People who were in the initial clinical trials didn’t gain weight or have a reduced sex drive on it.

Breastfeeding your little one? There’s not much data on the effects Zurzuvae could have on the baby. There’s some data on 14 women that show the medication did present in low levels in human breast milk. But the benefits of taking the medication may outweigh the risk.

Other drugs to treat depression have been shown to be helpful for treating PPD, like SSRIs, some of which are considered safe for breastfeeding. The downside of SSRIs is that they take longer to have an impact. “SSRIs which are the treatment we currently use can take up to 12 weeks to work, and [zuranolone] can work in as early as 3 days,” comments Sarah Oreck, MD, MS, reproductive psychiatrist and CEO of Mavida Health.

The need for PPD care

PPD can start during the end of pregnancy and/or after childbirth. Before this, the only treatment for PPD was Zulresso, a medicine given through an IV over the course of 60 hours. It had to be given in a health care facility. It was the first medicine that the FDA approved to treat PPD, but it came with a hefty price tag–it runs about $34,000 without insurance.

“Because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Testing zuranolone

Researchers tested Zurzuvae for the treatment of PPD in 347 adults that were part of two randomized, double-blind trials. The women met the diagnostic criteria for PPD, and their symptoms started during their last trimester or within four weeks after birth. 

In the first study, women got 50 mg or placebo once daily in the evening for 14 days. In the second study, women got another capsule containing zuranolone equivalent to 40 mg of Zurzuvae or they got a placebo. They stayed on those medicines for 14 days. They had positive changes in depressive symptoms according to a depression scale. Women taking the medicine had better improvements compared to those who were on a placebo. Plus, they were feeling good on day 42, which was weeks after the last dose. 

FDA approves Zurzuvae

The FDA gave the application priority review and approved it using the Fast Track designation. This means it was reviewed more quickly because there was an unmet need for the drug–in other words, nothing else was available except an expensive IV that essentially kept women in hospital instead of at home with their families.

The FDA said they wanted to see more studies on using zuranolone for other forms of depression. 

“It’s really great that this medication is coming out because if it is able to treat postpartum depression that effectively, then it would alleviate a lot of suffering,” Nirmaljit Dhami, MD, medical director of the Inpatient Perinatal Psychiatry Unit at El Camino Health’s Scrivner Center for Mental Health & Addiction Services in Mountain View, California, told USA Today.

Postpartum depression resources

If you’re experiencing any postpartum mood symptoms, no matter how mild, know that help is available. Reach out to your healthcare provider about next steps and potential treatment options, such as more support at home, therapy or medication. If you’re in crisis, reach out to a crisis hotline or dial 988 or 911 for immediate support.

The phone numbers listed below are available 24/7 to help you with suicidal thoughts or other mental health crises. 

• The National Maternal Mental Health Hotline: 1-833-943-5746 (1-833-9-HELP4MOMS)
  • Available in English and Spanish and in a completely confidential line.
• Postpartum Support International: 1-800-944-4773 (call or text)
  • Available in English and Spanish
• National Crisis Text Line: Text HOME to 741741
• National Suicide Prevention Hotline: Call or text 988
  • Available in English and Spanish