First-ever pill approved for postnatal depression treatment

The US Food and Drug Administration (FDA) has granted approval for the first-ever pill designed specifically for postnatal depression (PND) treatment. Zurzuvae (zuranolone) is an oral pill focused on addressing the unique hormonal and psychological factors that contribute to postnatal depression.

What is postnatal depression?

Postnatal depression affects approximately one in seven new mothers, causing debilitating symptoms that can impact their mental health and their ability to bond with their newborns and carry out everyday tasks.

Approximately one in eight British women experience depression during pregnancy (antenatal depression). A reported 25 per cent of women with postnatal depression still experience symptoms after their new baby turns one. The Royal College of Psychiatrists revealed that PND can spoil the experience of new motherhood and can strain their relationship with their infant and partner.

Zurzuvae has shown incredible promise in clinical trials and its recent double-blind, placebo-controlled phase three clinical trial found that zuranolone was highly influential in alleviating postnatal depression after only 14 days of use.

Advocates for maternal mental health have lauded the FDA's decision as a turning point in addressing the often-overlooked issue of postnatal depression. Organisations like the Postnatal Support International and Maternal Mental Health Leadership Alliance have long pushed for increased awareness, research, and resources to combat this pervasive condition.

Dr Tiffany R. Farchione, director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research said: "Postpartum [postnatal] 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.

"And, because postpartum [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."

What are the side effects and benefits of zuranolone?

The mild to moderate side effects of taking zuranolone for 14 days were reported to include
drowsiness, dizziness, and sedation. Participants of the clinical trial reportedly did not experience withdrawal symptoms, did not lose consciousness, or experience increased suicidal ideation or behaviour.

However, similar to other forms of antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs), some amount of zuranolone may be found in breast milk.

Dr Kristina M. Deligiannidis, lead author of the clinical trials for zuranolone and director of Women's Behavioral Health at Zucker Hillside Hospital, Northwell Health said: "We reported at the International Association for Women's Mental Health 2022 Regional Meeting that compared with the maternal dose, amounts of zuranolone in breast milk were low.

"Many health conditions that affect women are understudied, leaving women with fewer treatment choices. [The] development of [an] oral option may increase treatment access."

Postpartum treatment is even more important for people of colour as they are more likely to experience health disparities and complications during pregnancy and childbirth. These disparities can extend into the postpartum period, putting them at a higher risk for physical and mental health issues.

People of colour may also have different family structures and support networks compared to the majority population. Having commercially available postpartum depression treatment will help address these unique dynamics should a strong support system and community resources not be immediately available.

As the medical community ushers in a new era of maternal mental health support with the approval of the groundbreaking Zurzuvae pill, countless families are poised to benefit from improved postnatal mental well-being.

The FDA's decision not only offers hope to mothers who have endured the shadow of postnatal depression but also underscores the importance of prioritising mental health as an integral component of comprehensive maternal care.