Novel pill could aid postpartum depression symptoms

MEEFRO July 28, 2023

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If approved, the treatment could provide the first oral, at-home, neuroactive steroid therapy to treat postpartum depression (PPD).

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression (PDD),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper. The study investigated oral 50mg, 14-day neuroactive steroid zuranolone pill as a treatment for perinatal or postpartum depression.

Key data from the SKYLARK zuranolone study

Data published in the American Journal of Psychiatry demonstrated that 57 percent of the women taking zuranolone versus 38 percent of women taking placebo experienced a 50 percent or more improvement in their depressive symptoms at day 15.

At day 45, 61.9 percent of the trial participants given zuranolone compared to 54.1 percent of women receiving placebo, experienced an improvement of 50 percent or more in their depressive symptoms.

Research suggests that PPD is partly due to a disruption in the normal interaction between the nervous system’s stress response, ɣ-aminobutyric acid (GABA) signalling, and neuroactive steroids (NAS). The condition is underrecognised and undertreated, according to Dr Deligiannidis.

The SKYLARK findings support the potential for US Food and Drug Administration (FDA) approval of the first oral, at-home, neuroactive steroid therapy to treat postpartum depression.

About the SKYLARK trial

There were 200 patients in the SKYLARK study, with 196 female patients between ages 18 to 45 who received the drug. Zuranolone (50mg) or placebo was administered once daily for 14 days.

Phase III ROBIN trial

In 2021, Phase III results of the ROBIN clinical trial were published in the Journal of the American Medical Association (JAMA) Psychiatry. The trial demonstrated the improvement in depressive symptoms with zuranolone at 30mg versus placebo in patients with PPD. Based on the results, the safety and efficacy of 50mg of zuranolone was subsequently evaluated in the SKYLARK trial.