First Postpartum Depression Drug Fast Tracked and Licensed by FDA

On Aug. 4, 2023, the U.S. Food and Drug Administration (FDA) fast tracked licensure of the oral prescription medication Zurzuvae (zuranolone), manufactured by Sage Therapeutics, Inc. as a treatment for postpartum depression. Postpartum affects roughly one in seven women and typically begins after childbirth but, for some women, it can begin during later stages of pregnancy.^{1 2}

Although doctors have prescribed various drugs for mothers to address symptoms of depression after giving birth, this is the first FDA-licensed drug specifically targeting postpartum depression. Zurzuvae is prescribed as a 14-day treatment course.^{1 3}

Boxed Warnings Include Drowsiness, Suicide and UTI

Zurzuvae has a boxed warning stating that it can affect the ability to drive a vehicle and perform other potentially hazardous activities requiring concentration. Patients who take the drug may be unable to assess their degree of impairment. Other common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (that causes common cold symptoms), and urinary tract infection (UTI). The FDA said the drug may cause suicidal thoughts and behavior and may also cause fetal harm if taken while pregnant.¹

Zuranolone is a synthetic version of a naturally occurring substance in the body known as allopregnanolone, a neuroactive steroid that is a metabolite of progesterone. Allopregnanolone rises dramatically during pregnancy then has an abrupt drop after childbirth. Drugmakers believe this drop may contribute to postpartum depression. Brexanolone is another drug thought to reduce postpartum depression with similar biological mechanisms, but it is only available as an IV drip.¹

The antidepressant drugs classified as selective serotonin reuptake inhibitors (SSRIs), such as Prozac or Zoloft, are often prescribed for postpartum depression. However, SSRIs appear to take one to two months to begin to become effective.²

Some Mental Health Experts Say Therapy and Lifestyle Changes Should Be First Treatment for Most Postpartum Depression

Some concerns amongst maternal health experts include the fact that zuranolone was originally tested primarily on women with severe postpartum depression, not mild to moderate depression, and that patients should still consider therapy and lifestyle changes first as the gold standard of care.¹

Catherine Monk, PhD, professor of medical psychology at Columbia University’s Vagelos College of Physicians and Surgeons. stated:

We must address the social determinants of health in the causal pathway to postpartum depression and not let the excitement of a new medication overshadow these issues.¹

According to Judite Blanc, PhD, professor of psychiatry and behavioral sciences at the Miami University’s Miller School of Medicine, from a scientific, social, and ethical standpoint, Zuranolone’s single clinical trial should not be considered the panacea to tackle the maternal health crisis. She said:

Medications shouldn’t be the first or only line of treatment for mental health conditions, particularly among women, children, and historically oppressed populations.¹

Zuranolone Underwent Single 45-Day Trial

The 151 postpartum women participating in the zuranolone clinical trial that Sage Therapeutics used to obtain FDA licensure were only followed for 45 days and none of them were breastfeeding their infants. Dr. Blanc added that “we need further studies to assess the long-term impact of zuranolone, including among breastfeeding mothers, as well as the patient-child interaction.”¹

Within the limited 45-day trial, reportedly the 151 patients in the study saw a “clinically meaningful benefit” with significant improvements in depressive symptoms compared to those taking a placebo.¹ Because it was not tested on breastfeeding mothers, it is unknown whether the drug affects breastmilk supply.

The FDA granted the license application for zuranolone under a Priority Review and Fast Track designation, which expedites the pace at which drugs and biologicals are evaluated and approved based upon the justification that the product fills “unmet needs.”³

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