The majority of treatment emergent adverse events were mild to moderate in severity.
New data shows zuranolone, a potential treatment for postpartum depression (PPD), has met all the primary and key secondary endpoints in the phase 3 SKYLARK study.
Sage Therapeutics and Biogen announced the positive data for the investigational oral drug with an aimed dosage of two-week, once-daily treatment for PPD, as well as major depressive disorder (MDD).
In the randomized, double-blind, placebo-controlled SKYLARK study, the investigators found women treated with zuranolone 50 mg (n = 98) showed a statistically significant and clinically meaningful improvement in depressive symptoms at day 15, which was the primary endpoint of the study, compared to placebo (n = 97), measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score.
The study also showed the least-squares mean CFD in HAMD-17 total score at day 15 for women treated with zuranolone 50 mg was -15.6 (0.82) compared to -11.6 (0.82) for women who treated with 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 Kristina Deligiannidis, MD, principal investigator of the SKYLARK Study and Associate Professor, the Feinstein Institutes for Medical Research, in a statement. “These encouraging results are another important step in efforts to develop a novel treatment option for patients who suffer from this prevalent condition.”
For secondary endpoints, the treatment showed rapid and statistically significant improvement in depressive symptoms as early as day 3 for patients treated with zuranolone 50 mg compared to placebo. This was sustained at all measured timepoints through day 45 as measured by CFD in HAMD-17 total score.
Zuranolone resulted in a statistically significant improvement in key secondary endpoint of change from baseline in the Clinical Global Impression Severity (CGI-S) scale, which rates disease severity, at day 15 compared to placebo (zuranolone -2.2 vs. placebo -1.6, P = 0.0052).
For safety, the treatment was generally well-tolerated with a safety profile consistent with what has been observed in the clinical development program.
The majority of treatment emergent adverse events were mild to moderate in severity for either treatment groups, with the most common events being somnolence, dizziness, sedation, headache, diarrhea, nausea, urinary tract infections, and COVID-19. There was no evidence of withdrawal symptoms or increased suicidal ideation or behavior identified as assessed by the 20 item Physician Withdrawal Checklist and the Columbia Suicide Severity Rating Scale, respectively.
“Postpartum depression is frequently under-recognized, and it can take time for women to be clinically diagnosed and treated,” said Katherine Dawson, MD, Head of the Therapeutics Development Unit at Biogen, in a statement. “Our hope is to be able to offer an innovative treatment option to potentially reduce the overwhelming impact postpartum depression can have on women and their families.”
Postpartum depression is 1 of the more common medical complications during and after pregnancy, with approximately 1 in 8 women who have given birth suffering from it in the US, equating to 500,000 women annually.