Postpartum depression drug trial shows positive results

Zuranolone, an investigational oral drug for treating postpartum depression in women, met its primary and secondary endpoints in a phase 3 trial, Sage Therapeutics and Biogen announced in a release.

In the phase 3 SKYLARK study, women treated with 50 mg of zuranolone (n = 98) demonstrated statistically significant and clinically meaningful improvement for depressive symptoms after 15 days, compared with women receiving placebo (n = 97).

“Reducing suffering from postpartum depression as rapidly and effectively as possible to restore maternal mental health is of the utmost importance for moms and their babies,” Kristina M. Deligiannidis, MD, principal investigator of the study and associate professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said in the press release.

Study participants were measured from baseline by the change in score on the 17-item Hamilton Rating Scale for Depression. The least-squares mean change from baseline scores at day 15 were –15.6 in women who received zuranolone, and –11.6 for women who received placebo.

“These encouraging results are another important step in efforts to develop a novel treatment option for patients who suffer from this prevalent condition,” Deligiannidis said.

For secondary endpoints, women were assessed with the Clinical Global Impression Severity scale at day 15, a clinician-administered seven-point scale that rates disease severity at the time of the test. Women taking 50 mg zuranolone showed significant improvement compared with women taking placebo (zuranolone, –2.2 vs. placebo, –1.6).

Additionally, 50 mg zuranolone was well tolerated and demonstrated a safety profile that was consistent with that observed in the clinical development program to date.