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.

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.

U.S. Food and Drug Administration. FDA approves first treatment for post-partum depression. March 19, 2019.

 

“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.

U.S. Food and Drug Administration. FDA approves first treatment for post-partum depression. March 19, 2019.

Planned Parenthood. Postpartum Depression.

 

 

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.

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.

InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006-. Depression: How effective are antidepressants? Updated June 18, 2020.

 

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.”