FDA Approves Postpartum Depression Drug That Works Within Days

August 12, 2023

The first oral treatment for postpartum depression (PPD), zuranolone, has been approved by the Food and Drug Administration (FDA) and is expected to launch later this year. The medication, brand name Zurzuvae, is taken in pill form once daily for 14 days, and improvement of symptoms may be noticed as soon as three days after beginning treatment, researchers found.

The only other FDA-approved medication for PPD, brexanolone (brand name Zulresso), must be administered as a single, 60-hour IV drip in a healthcare facility. Because of zuranolone’s quick onset of action, and the accessibility of the pill formulation, it offers the promise of much-needed help for scores of new mothers battling postpartum depression, including those with ADHD who are up to five times as likely as their neurotypical counterparts to develop PPD.

“A Serious, Potentially Life-Threatening, Condition”

In a recent press release, Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, described PPD as “a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child.” PPD, which occurs in 12.5% of women, according to the CDC, is a major depressive episode that typically begins after childbirth and persists for months or, sometimes, years. According to a 2023 ADDitude survey of 1,976 women, 57% of those who experienced pregnancy also reported feelings of postpartum depression.

The impact of PPD is felt by both mother and infant, as the condition often interferes with the parent-child bond, and can contribute to developmental delays. In extreme cases, postpartum depression causes suicidal ideation and behavior, which can lead to tragic consequences; studies show that approximately 1 in 5 maternal deaths postpartum are caused by suicide.¹ According to a study in the Journal of Women’s Health, only one half of women who reported experiencing PPD received treatment.² The ADDitude survey confirmed this finding.

Two randomized, double-blind, placebo-controlled studies were considered by the FDA as part of its approval process for zuranolone. The most recent study, published last week in the American Journal of Psychiatry, found that, among 196 women with postpartum depression, the participants who received zuranolone at 50 milligrams daily demonstrated “significant improvements in depressive symptoms.” Upon completion of the 14-day treatment, 57% of them reported a 50% or higher improvement in their depressive symptoms, as opposed to 38% of those on placebo. Four weeks post-treatment, 62% of participants who received zuranolone, contrasted with 54% on a placebo, reported 50% or higher improvements.³

Researchers found that the most common side effects associated with zuranolone were drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infection. To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking zuranolone. The medication may cause fetal harm, and women are advised to use contraception while taking the medication. As with other medications used to treat depression, zuranolone can cause suicidal ideation and behavior.

Improvement in Days, Not Weeks

The rapid onset of action (in some cases, within three days), short duration of the treatment (two weeks), and easy administration (one pill daily) sets the treatment apart from all previous medications for PPD. The antidepressants historically used to treat depression, selective serotonin reuptake inhibitors (SSRIs) such as Zoloft and Prozac, typically take four to six weeks to reach full effect, and are often taken indefinitely. When the first drug specifically created to treat postpartum depression, brexanolone, was approved in 2019, it marked a breakthrough in the treatment of the condition. However, because brexanolone can only be administered via an intravenous drip, requiring a costly two-day stay in a healthcare facility, it has not been widely used.

Brexanolone and zuranolone were both developed by Biogen and Sage Pharmaceuticals and work in much the same way. Both medications modulate levels of allopregnanolone, a neuro-active steroid that is made in the body from the hormone progesterone, which rises during pregnancy and plummets post-birth.

Now that zuranolone has been approved by the FDA, the U.S. Drug Enforcement Administration must complete a review over the next 90 days, during which it will assign a schedule to the medication, which is a controlled substance. There is no information regarding the expected price of the medicine, which is expected to launch in the last quarter of 2023.

The developers of zuranolone also applied for approval to use the drug for the treatment of major depressive disorder. The FDA did not issue a decision on this indication.

ADHD Increases Risk of Postpartum Depression

The new medication could offer desperately needed relief for new mothers with ADHD, who are five times more likely to develop postpartum depression according to a study in the Journal of Affective Disorders.⁴

“ADHD is an important risk factor for depression and anxiety disorders postpartum,” wrote the authors of the study in the Journal of Affective Disorders. “Therefore, ADHD needs to be considered in maternal care, regardless of sociodemographic factors and other psychiatric disorders.”

“PPD made it hard to get through anything without going into a guilt-depression spiral,” recalls Kathyrn, an ADDitude reader with ADHD who lives in Washington. “At first I thought it was just exhaustion from being a new mom but it turns out crying that often isn’t normal, even if you’re exhausted. I would wish I could disappear and sleep forever, then I’d feel guilty for thinking that when I had a brand-new human I loved so much, then I’d feel depressed for being a bad mom. Spiral, repeat.”

These harrowing symptoms are all too common among new mothers with ADHD. According to the ADDitude survey, the most common symptoms of PPD were:

• feelings of worthlessness, shame, guilt, or inadequacy: 76%
• crying spells: 76%
• mood swings: 66%
• irritability: 62%

One-third of respondents who experienced PPD reported thoughts of hurting themselves or others, and 6% reported engaging in self-harm.

Postpartum depression typically begins after childbirth, and can persist for many months, and oftentimes, years. Among ADDitude readers who experienced PPD, the depression lasted:

• 1-3 months: 13%
• 4-6 months: 19%
• 7-13 months: 22%
• 1-2 years: 14%
• More than two years: 14%

While the approval of zuranolone marks a leap forward in the treatment of PPD, important questions remain. Participants were not followed past 45 days, making the sustainability of treatment beyond that point unclear. It is unknown, too, whether zuranolone will be safe for breastfeeding mothers, and there is no information as to the cost of the treatment, a primary consideration for many mothers. Still, the approval of zuranolone no doubt offers hope for countless new mothers and their families.

Says Farchione: “Having access to an oral medication will be a beneficial option for many women coping with extreme, and sometimes life-threatening, feelings.”

Get Help

To contact the Suicide & Crisis Lifeline, call or text 988 or visit www.988lifeline.org.

View Article Sources

Save

• Facebook
• Twitter
• Instagram
• Pinterest