Sunday, November 26, 2023
Alexander Papp, MD
The first oral pill approved by the US Food and Drug Administration (FDA) to treat postpartum depression, called Zurzuvae, developed by Sage Therapeutics, is now available by prescription. The medication, approved in August, is currently available only at specialty pharmacies and has to be shipped directly to patients. The drug, administered as two 25-milligram capsules per day for 14 days, has shown significant reductions in depressive symptoms within three days, lasting through at least 45 days, according to clinical trials.
Zurzuvae is the brand name for Zuranolone, a novel antidepressant molecule, whose mechanism of action is distinct from traditional antidepressants, as it does not involve the pathways using serotonin, norepinephrine, or dopamine. Zuranolone’s action is rapid, providing relief within days, in contrast to the delayed onset typically associated with traditional antidepressants. Chemically it is closely related to a hormone the blood level of which fluctuates widely during childbirth.
Postpartum depression affects about 1 in 7 new mothers and can have debilitating symptoms, including crying spells, difficulty bonding with the baby, feelings of hopelessness, suicidal ideation and even urges to harm the newborn. Zurzuvae’s reported quick onset of action by Day 15 has the potential to make a profound difference, offering a new option for women with postpartum depression.
However, the cost of Zurzuvae stands at $15,900 per course before insurance, prompting grave concerns about accessibility. We can bet that insurance companies will require patients to try less expensive SSRIs before covering the new treatment, at which point the speedy onset of action of this new drug will be made irrelevant. The price is noted to be less than half that of Sage’s earlier postpartum depression drug, Zulresso, which costs about $35,000 and requires IV infusion over 60 hours in a hospital setting.