Zuranolone safe, effective for postpartum depression

Use of zuranolone significantly improves depressive symptoms, with no serious side effects, in women with severe postpartum depression (PPD), a common perinatal complication with adverse maternal and infant outcomes, results of a phase III trial have shown.

In this trial, the investigators randomly assigned 196 women with severe PPD to receive zuranolone 50 mg/day (n=98) or placebo (n=98) for 14 days.

Change from baseline in total score on the 17-item Hamilton Depression Rating Scale (HAM-D) at day 15 was the primary endpoint. Secondary endpoints included change from baseline in HAM-D score at days 3, 28, and 45, as well as change from baseline in Clinical Global Impressions severity (CGI-S) score at day 15. Adverse events (AEs) were also assessed.

Of the patients, 170 completed the 45-day study period. Treatment with zuranolone was associated with a significant improvement in depressive symptoms at day 15 as compared with placebo (least squares mean [LSM] change from baseline in HAM-D score, ‒15.6 vs ‒11.6; LSM difference, ‒4.0, 95 percent confidence interval, ‒6.3 to ‒1.7).

Likewise, significant improvements in depressive symptoms were observed at days 3, 28, and 45. Zuranolone also resulted in significant improvements in CGI-S score relative to placebo.

In terms of AEs, the most common ones were somnolence, dizziness, and sedation. No loss of consciousness, withdrawal symptoms, or increased suicidal ideation or behaviour were noted.

“In this trial, zuranolone demonstrated significant improvements in depressive symptoms and was generally well tolerated, supporting the potential of zuranolone as a novel, rapid-acting oral treatment for PPD,” the investigators said.

Zuranolone is a positive allosteric modulator or synaptic and extrasynaptic GABA-A receptors and neuroactive steroid used to treat adults with PPD.