The complex and time-consuming task of treating depression often involves a trial-and-error approach to finding the right drug treatment, which can take weeks or even months. This challenge extends to postpartum depression, affecting up to 20% of new mothers within the first six weeks after childbirth [1].

A groundbreaking development occurred on August 4, with the US Food and Drug Administration’s (FDA) approval of zuranolone, also known as Zurzuvae, for addressing postpartum depression [2]. Created by Sage Therapeutics and Biogen, two Massachusetts-based biotechnology companies, this oral treatment entails a 14-day regimen of daily pills, marking a significant advancement in tackling this major depressive condition.

While Sage Therapeutics and Biogen sought FDA approval for both postpartum depression and major depressive disorder, the agency decided to green-light zuranolone specifically for postpartum depression without elaborating on the rationale behind this choice [3].

Studies on zuranolone encompassed individuals with postpartum depression and major depressive disorder [4]. Among those with postpartum depression, statistically significant improvements in depression scores were observed after two weeks in patients taking the drug, compared to those receiving a placebo. These benefits appeared to persist even a month after treatment cessation.

The drug’s remarkable rapid onset of action, potentially within three days, holds promise as a game-changer in depression treatment. Unlike antidepressant therapies that may take months to alleviate symptoms, zuranolone’s prompt effects could enhance the effectiveness of complementary interventions like psychotherapy.

For women contending with postpartum depression, swift symptom reduction could revolutionize their interaction with their infants, facilitating a return to a healthier emotional state. Dr Kristina Deligiannidis, lead investigator of the zuranolone trials, underscores its capacity to alleviate the enduring impacts of postpartum depression on the neurodevelopment of infants, as highlighted in a TIME news release [4].

Zuranolone works faster because it targets a specific receptor in the brain called GABA-A, which helps control how nerves function and how we respond to stress. In postpartum depression, this control system doesn’t work well, leading to problems with chemicals in the brain that are linked to feeling depressed. Zuranolone helps fix the GABA-A system, which then helps the brain regulate itself more effectively.

Unlike a similar drug called brexanolone (Zulressa), which needs to be given through a needle in a hospital-like setting over three days because it can make you unconscious, zuranolone is more convenient. Zuranolone can be taken as a pill with fewer and milder side effects.

Even though both drugs affect the same brain system, zuranolone is better regarding safety and how easy it is to take. The side effects, like feeling tired, were not too bad and didn’t make people pass out.

The FDA cautions about potential drowsiness and advises against driving or operating heavy machinery for up to 12 hours after taking zuranolone [2]. Concerns arise for breastfeeding mothers, as the drug may cause fetal harm. 

Limited data on zuranolone’s impact on developing babies is available because study participants temporarily discontinue breastfeeding during treatment. However, initial findings suggest minimal drug transfer to breast milk.

While the long-term effects of zuranolone remain uncertain, early intervention holds promise for durable outcomes in depression management. Its availability offers new hope for women to acknowledge and seek help for their symptoms, whether through zuranolone or other therapies like talk therapy.

[1] https://www.ncbi.nlm.nih.gov/books/NBK519070/
[2] https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression
[3] https://investors.biogen.com/news-releases/news-release-details/biogen-and-sage-therapeutics-announce-fda-accepts-filing-new
[4] https://www.psychiatrist.com/jcp/depression/zuranolone-vs-placebo-in-mdd/
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246337/