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Zuranolone: What a New Perspective Means for an Age-Old Problem

Updated: Sep 28, 2023

By Julia Peavey

Hippocrates of Kos: a classical Greek physician of the 4th century B.C.E., known for his medical writings collected by the Library of Alexandria.

Jean-Etienne Esquirol: a French psychiatrist of the 19th century, known for his statistical analysis of intellectual disability.

Brooke Shields: an American actress and model of today, known for her controversial breakout role as a child prostitute in the film Pretty Baby.

Their common thread? Each is a key part of the history of postpartum depression’s recognition as a condition. Hippocrates wrote of the “puerperal fever,” Esquirol of the “mental alienation of nursing women,” Shields of the “large white elephant sitting in the room that no one was supposed to talk about.”

Clinicians have noted the association between the postpartum period and mood disturbances for centuries, and its presence has been documented across cultures and times as everything from evil spirits to hysteria. Postpartum depression (PPD), however, is a relatively recent term - the condition itself was not recognized as a psychiatric disorder until 1994 with the 4th edition of the DSM. Thought to affect 1 in 7 women, PPD is a condition that can include symptoms of crying spells, disruption of the maternal-infant bond, inability to sleep, and feelings of guilt, worthlessness, and hopelessness. It differs from “baby blues,” which are found in over 85% of new mothers and cause emotional changes for up to two weeks after birth. Unlike “baby blues,” PPD doesn’t fade; at its worst, it's debilitating, causes thoughts of harming one’s self or baby, and increases risk of suicide.

PPD is common, it’s serious, it’s treatable; in fact, it has been all of these things. It has been over 60 years since the FDA approved its first medication for treating Major Depressive Disorder, but it wasn’t until August 4th of this year that the FDA first approved an oral treatment specifically for PPD. This approval is a huge step forward for maternal healthcare. It’s also a sign of how severely our current standards of maternal healthcare are lacking.

The pill, zuranolone (brand name Zurzuvae), has demonstrated effectiveness in two randomized controlled trials. In the first study, 151 women with PPD received 30 mg of a zuranolone-based product or a placebo once a day for 14 days. In the second study, 196 women with PPD received 50 mg of Zurzuvae or a placebo once a day for 14 days. Both studies revealed that patients in the zuranolone group exhibited significant improvement in depressive symptoms compared to controls, a result which took effect as early as three days into treatment and was retained four weeks after the final dose.

In an FDA press release following the approval decision, Dr. Tiffany Farchione, director of the FDA’s Center for Drug Evaluation and Research Division of Psychiatry, stated that “having access to an oral medication will be a beneficial option for many…women coping with extreme, and sometimes life-threatening, feelings.”

Dr. Wendy Davis, Executive Director of the nonprofit Postpartum Support International, also hailed the decision as “welcome news for the estimated 500,000 women in the United States who report experiencing symptoms of this devastating and often misunderstood illness each year.”

To understand the true extent of Zurzuvae’s significance, one must first understand the disheartening nature of current PPD treatment. Traditional antidepressants can take weeks to have an effect, leaving new mothers experiencing PPD to suffer in silence amidst dangerously prolonged symptoms or navigate the worlds of off-label treatment and psychotherapy without support. The only other FDA-approved postpartum depression treatment currently available is delivered through an emergency IV infusion of brexanolone (brand name Zulresso) - a 60 hour, $34,000 process. Significant barriers to this treatment include its price tag, side effects, and the necessity of a healthcare setting for its administration.

Zurzuvae, due to its pill form, may be taken in one’s own home, giving it a significant advantage in accessibility. Yet it will take time to know what the cost of Zurzuvae may be and when it will reach markets, making it a long road ahead. Oral medication for PPD will never stand as a be-all and end-all solution to the condition; while the pill may be effective in some cases, others are best treated by additional forms of intervention, lifestyle changes, and therapeutic care. Nonetheless, the FDA’s decision is notable because it sheds light upon PPD as a common yet often stigmatized condition, one that is far more rampant than last-resort emergency room infusion treatment would imply.

The recency of the research studies that enabled this approval makes larger observations, too. FDA approvals have slowed in the past few years and, not only that, healthcare research has notoriously underrepresented women and underfunded research pertaining to women for decades - just one of the reasons that women are more likely to be misdiagnosed with psychiatric and medical conditions. Further, the US lags behind other well-developed nations in maternal care, having the highest maternal mortality rate of high-income nations. This precedent is not an acceptable one. Much like the words of Hippocrates of Kos, Jean-Etienne Esquirol, and Brooke Shields, the FDA’s recent approval affects our collective view of PPD treatment in a way that inevitably brings the topic of maternal care, particularly of disparities in its accessibility, into the public eye. Considering the preventability of pregnancy-related deaths, continued innovation in and attention to standardized care and postpartum treatment will save the lives of infants and mothers alike.


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