Zuranolone in postpartum depression met all endpoints

Sage Therapeutics (Nasdaq: SAGE) rose as much as 10% to $34.81 after, along with partner Biogen (Nasdaq: BIIB), it announced that the Phase III SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints.

Women treated with zuranolone 50mg (n=98) demonstrated a statistically-significant and clinically-meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo (n=97) as measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. The least-squares (LS) mean (SE) CFB in HAMD-17 total score at Day 15 for women who received zuranolone 50mg was -15.6 (0.82) compared with -11.6 (0.82) for women who received placebo (LS mean difference -4.0 points; p=0.0007).

“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,” said Dr Kristina Deligiannidis, principal investigator of the SKYLARK Study and Associate Professor, the Feinstein Institutes for Medical Research in Manhasset, New York, adding: “These encouraging results are another important step in efforts to develop a novel treatment option for patients who suffer from this prevalent condition.”