This August, the FDA approved the first postpartum depression pill.
Since 2019, PPD treatment has only been administered intravenously in healthcare settings. Before that, there was no specific treatment for the condition.
Experts say the approval is a big step in giving patients more treatment options—but it’s still just one step.
The Food and Drug Administration (FDA) on Friday approved the first postpartum depression (PPD) pill, addressing a decades-long treatment gap and putting a spotlight on maternal mental health care.
Before last week, the only treatment for PPD was brexanolone (Zulresso), a medication available exclusively through an intravenous (IV) route, which the FDA approved in 2019. Before that, there were no FDA-approved drugs to treat PPD.
The new treatment, zuranolone (Zurzuvae), will be more efficient than its predecessor, brexanolone, as the pill can be taken orally. The FDA recommends patients take a 50mg dose of zuranolone once daily, specifically in the evening with a “fatty meal.” The recommended treatment course is 14 days.
In contrast, brexanolone is administered through a continuous IV over 60 hours or two and a half days. Patients need to be enrolled in a special program before receiving the treatment and must receive the treatment at a certified healthcare facility.
“The fact that zuranolone can be taken orally at home and over a shorter period of time may improve accessibility for certain populations,” says Asima Ahmad, MD, MPH, FACOG, chief medical officer and co-founder of Carrot Fertility, a global inclusive fertility healthcare that provides services ranging from egg and sperm freezing to adoption. Dr. Ahmad is double board-certified in reproductive endocrinology and infertility and obstetrics and gynecology.
PPD is a form of depression that can impact pregnant people shortly after they give birth. Similar to other forms of depression, it is characterized by sadness and decreased ability to feel pleasure, according to the FDA. Among other symptoms, people with PPD may experience intense sadness, cognitive impairment, lethargy, or suicidal thoughts. PPD can start between one to three weeks after giving birth and can last for weeks or months, depending on the individual, according to Planned Parenthood.
Zuranolone safety and effectiveness
From a review of the trials, zuranolone appears to have a lower side effect profile than brexanolone, which has a risk of a sudden loss of consciousness, says Dr. Ahmad. Further, in comparison to other antidepressants on the market not targeted for PPD, uranolone may be likewise less likely to produce side effects like weight gain or sexual dysfunction, she adds.
“Both the lower incidence of side effects and the short-term regimen, which could help some feel less stigma around having to use an antidepressant, could potentially improve compliance,” Dr. Ahmad says.
However, regarding how the drugs work inside the body, Dr. Ahmad adds that zuranolone and brexanolone have similar mechanisms of action.
Focusing in on maternal mental health
PPD treatments aside, zuranolone works quicker than other prescription antidepressants and is taken over a shorter period of time. Other antidepressants may take one to several weeks to settle into a person's system and provide benefits. In contrast, people should reap zuranolone’s benefits within two days of taking the pill and should only take it for two weeks, according to the FDA.
Considering everything, Dr. Ahmad says that this pill may be a good option for people suffering from postpartum depression,” particularly for people in need of a medication that produces a quick response.
However, she adds that this may not be the solution for everyone with PPD, as the condition is diverse and strikes people differently.
“Postpartum mental health is complicated and varied; some experience mild emotional disruptions because of hormonal shifts, while others face postpartum blues, PPD, anxiety, and, in severe cases, psychosis or even suicide,” says Dr. Ahmad. “In a time when we are seeing rising maternal mortality rates and significant racial disparities in maternal outcomes, we need to focus on solutions.”
Parijat Deshpande, an author, speaker, and filmmaker focused on improving outcomes of high-risk pregnancies, posted on LinkedIn that she was “underwhelmed” by the approval. Deshpande called the pill an attempt to find an “an individualistic solution to a systemic problem,” which requires multifaceted solutions. As such, she encouraged her feed to continue to view PPD as diverse and to advocate for more and better treatments going forward.
“I'm not anti-pill if it actually works the way it says it does and is actually accessible to whoever needs it, whenever they need it,” Deshpande said. “But the pill is not a magic solution.”
Deshpande added that the approval is “great news about the advancements in technology, but we can do much, much better for our birthing people and new parents.”
What this means for you
The FDA approved the first postpartum depression pill this August, granting the approval to Sage Pharmaceuticals. Now, people with postpartum depression may be able to receive treatments in pill form or IV form. In the future, doctors hope they will have even more options.