On Friday, the U.S. Food and Drug Administration (FDA) approved the first pill to treat postpartum depression (PPD). Zuranolone, which will be marketed and sold under the brand name Zuzurvae, is a once-daily pill intended specifically to help mothers suffering depressive symptoms after childbirth.
While there are many anti-depressants currently on the market, zuranolone offers unique benefits in the treatment of PPD. Here’s what experts say you need to know about the new medication and when it’s expected to be available.
What is zuranolone?
Zuranolone is a 14-day treatment for PPD administered via an oral pill. It was developed by Biogen and Sage Therapeutics, Inc. According to the FDA, the drug’s effectiveness was analyzed in two randomized clinical trials involving women with severe postpartum depression. In both studies, women receiving doses of zuranolone experienced “significantly more improvement” in their depressive symptoms during the 14-day treatment period than those taking placebos. Participants continued to report improvement in their symptoms after four weeks.
According to Biogen, Zurzuvae is expected to launch in the fourth quarter of 2023, shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration. It will be available by prescription only.
What makes zuranolone different from other antidepressants?
Traditionally, postpartum depression has most often been treated with therapy and a number of non-PPD specific antidepressants. “There is no shortage of medications that treat depression, but zuranolone has been studied as a form of treatment for postpartum depression that has a more rapid response and shorter course of treatment than some other medications currently available,” says Dr. Asima Ahmad, a Chicago-based reproductive endocrinologist, infertility specialist and the co-founder and Chief Medical Officer of Carrot Fertility.
As Ahmad explains, patients taking zuranolone may notice the effects of the medication as early as on day three of treatment, compared with other oral antidepressants that can take as many as six to 12 weeks to have an effect. In addition to it’s fast-acting properties, the medication:
- Comes in a pill form that can be taken orally.
- Can be taken at home.
- Requires a shorter (14-day) treatment time.
While zuranolone is the first pill approved to treat PPD, it isn’t the first postpartum depression-specific medication overall. There is one other drug called brexanolone that was approved in 2019. In contrast to zuranolone, Ahmad explains that brexanolone must be administered via intravenous therapy (IV) over the course of 60 hours and is associated with severe side effects, like sudden loss of consciousness.
Both the lower incidence of severe side effects and the shorter treatment regimen of zuranolone could help some feel less stigma around needing to take an antidepressant, Ahmad adds. The fact that it’s an oral pill may also improve accessibility.
“Zuranolone has been studied as a form of treatment for postpartum depression that has a more rapid response and shorter course of treatment than some other medications currently available.”
— Dr. Asima Ahmad, a Chicago-based reproductive endocrinologist and the co-founder and Chief Medical Officer of Carrot Fertility
Why do we need a pill specifically designed to treat PPD?
While other medications can help treat the symptoms of PPD, zuranolone helps address the lack of treatments specifically designed to support the needs of postpartum mothers. “In a time when we are seeing rising maternal mortality rates, and significant racial disparities in maternal outcomes, we need to focus on solutions, and that includes addressing postpartum depression,” says Ahmad.
Postpartum depression is a serious mental illness that affects about one in seven new mothers. The risk is even higher for Black and Hispanic mothers. Symptoms of PPD can occur immediately following a birth or for up to a year afterwards and include:
- Severe mood swings.
- Anxiety.
- Insomnia.
- Intense irritability.
- Difficulty bonding with one’s baby.
In severe cases, women may develop postpartum psychosis and/or thoughts of suicide of self-harm. Maternal deaths from suicide account for 20% of postpartum deaths.
“Postpartum depression is 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,” notes Tiffany R. Farchione, a director at the FDA’s Center for Drug Evaluation and Research, in the administration’s press release. “And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development. Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
While the drug presents a promising new treatment option for people with PPD, it’s important to note that it may not be the right fit for everyone. Those interested in taking zuranolone should talk with their doctor about their unique symptoms, medical history and the best methods of treatment. Additionally, Ahmad stresses that it’s still important for postpartum mothers to receive other forms of support.
“In general, a medication should not be used as a substitute for other measures to improve one’s mental health,” she explains. “People should still have comprehensive treatment plans in place, including a support system — doulas and lactation consultants can be a great resource — and medical providers, such as a psychiatrist, therapist, etc.”
What are the side effects of zuranolone?
It’s important to ask your doctor about your personal risk of side effects when taking any new medication. The FDA reports that the most common side effects of taking zuranolone include:
- Drowsiness.
- Dizziness.
- Diarrhea.
- Fatigue.
- Nasopharyngitis (the common cold).
- Urinary tract infection.
The medication’s labeling will also contain a boxed warning noting that it can impact a person’s ability to drive and perform other potentially hazardous activities. To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking the drug.
The bottom line
The approval of the first pill to treat postpartum depression is a milestone moment in women’s healthcare, and it offers a new beacon of hope to thousands of people who’ve experienced symptoms of PPD. Not only is zuranolone said to act faster than other antidepressants, but it also offers a more accessible medication option for people seeking postpartum depression care.
As the U.S. faces a maternal health crisis, research and treatments that specifically address postpartum care are vitally important. The introduction of this medication highlights the need for postpartum women to have access a broad support network and a variety of treatments to ensure their continued health. Those experiencing symptoms of postpartum depression should speak with their doctors to see which treatment option is right for them.
