Brexanolone Shows Promise for Postpartum Depression
Brexanolone achieved the primary endpoint in both clinical trials, reducing mean HAM-D score at 60 hours and maintained to 30 days.
Sage Therapeutics announced positive top-line results for brexanolone from the Hummingbird Phase 3 program which included patients with moderate and severe postpartum depression (PPD). Brexanolone is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors.
The Phase 3 trials were both multicenter, randomized, double-blind, parallel group, placebo-controlled studies designed to evaluate the safety and efficacy of brexanolone in women with moderate to severe PPD (Study 202B: A Study to Evaluate SAGE-547 in Patients With Severe Postpartum Depression; ClinicalTrials.gov identifier NCT02942004 and Study 202C: A Study to Evaluate SAGE-547 in Patients With Moderate Postpartum Depression; ClinicalTrials.gov identifier NCT02942017) The primary endpoint in both trials was mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score compared to placebo at 60 hours.
Compared to placebo, brexanolone achieved the primary endpoint in both trials (Study 202B: P =.0242 for 90 µg/kg/h dose and P =.0011 for 60 µg/kg/h dose; Study 202C: P =.0160 for 90 µg/kg/h dose). Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials.
Brexanolone was found to be generally well tolerated in both studies; the most common adverse events were headache, dizziness, and somnolence.
"These data meaningfully advance our understanding of PPD and may prompt medical professionals to evaluate how PPD is perceived, identified and treated within their practices in the future," said
Sage Therapeutics plans to file a New Drug Application (NDA) with the Food and Drug Administration (FDA) in 2018.
Sage Therapeutics announces brexanolone achieves primary endpoints in both phase 3 clinical trials in postpartum depression [news release]. Cambridge, MA: Sage Therapeutics. http://investor.sagerx.com/news-releases/news-release-details/sage-therapeutics-announces-brexanolone-achieves-primary. Published November 9, 2017. Accessed November 22, 2017.