This website is made possible by third party financial support from Sage Therapeutics, Inc. and Biogen Inc.

This website is made possible by third party financial support from Sage Therapeutics, Inc. and Biogen Inc.

Brexanolone Yields Rapid Improvement for Patients with Postpartum Depression

Brexanolone Yields Rapid Improvement for Patients with Postpartum Depression

July 23, 2021

A novel, rapid-acting antidepressant demonstrates a rapid and sustained improvement in symptoms for patients with postpartum depression.

postpartum

Brexanolone demonstrates a rapid and sustained improvement in symptoms for patients with postpartum depression, according to a recent post hoc analyses published in the Journal of Women’s Health.

The United States Food and Drug Administration approved brexanolone, an injection administered through a 60-hour intravenous infusion, for the treatment of postpartum depression in 2019 following two Phase 3 randomized clinical trials.

Previously, barriers to treatment for postpartum depression included a 6–12-week delay to achieve optimal improvement, side effects impairing adherence to treatment, and withdrawal effects associated with more traditional antidepressant treatments.

“In the Phase 3 trials, [brexanolone] BRX achieved the primary endpoint of significantly greater reduction in depressive symptoms, as measured by least-squares mean reduction in 17-item Hamilton Rating Scale for Depression (HAMD-17) total score at the end of infusion (hour 60) compared with placebo,” wrote Margaret E Gerbasi, PhD, Sage Therapeutics, Inc, Cambridge, Massachusetts, and co-researchers.

There is no specific estimate for postpartum depression on the HAMD-17 scale. Researchers crafted this analysis to explore outcomes for patients with postpartum depression, intending to determine postpartum depression-specific HAMD-17 meaningful change thresholds and help inform health care decision-making.

Researchers pooled data from the Phase 3 trials and one Phase 2 trial that compared the safety and efficacy of brexanolone to placebo for treatment of patients with postpartum depression. All studies were multicenter, randomized, double-blind, placebo-controlled trials conducted in the US, and included women aged 18 to 45.

A total of 209 patients were included in the analyses. Patients received 60-hour infusion of brexanolone or placebo and were evaluated at hour 60 and day 30 for postpartum depression-specific HAMD-17, group-level minimal important difference, patient-level meaningful change, and Clinical Global Impression of Improvement (CGI-I) response.

Secondary endpoints included evaluating relative risk, number needed to treat, and number need to harm data from treatment arms.

Patients treated with brexanolone had a higher likelihood of rapid and sustained HAMD-17 scale improvements as well as CGI-I response. Compared to placebo-treated patients, patients treated with brexanolone demonstrated clinically meaningful improvements as early as 60 hours and sustained to day 30.

The minimal, moderate, and large meaningful change thresholds were estimated to be −9, −15, and −20 points, respectively.

According to researchers, the likelihood of being a responder or remitter, as measured by relative risk, was significantly higher in the brexanolone treatment arm relative to placebo arm for both HAMD-17 and CGI-I responders and HAMD-17 remitters at hour 60, as well as for sustained CGI-I responders and HAMD-17 remitters at day 30. 

The most common adverse events were somnolence, dry mouth, loss of consciousness and hot flush.

To the researcher’s knowledge, this is the first article to propose PPD-specific estimates of HAMD-17 meaningful differences and patient-level meaningful change.

“Patients treated with [brexanolone] BRX demonstrated a higher likelihood of rapid and sustained HAMD-17 and CGI-I improvements,” concluded Dr Gerbasi et al. “The data reported herein further support the positive clinical profile of BRX and provide valuable insights for health care decision-makers evaluating its placement within the [postpartum depression] PPD treatment cascade.”