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. 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 90µg/kg/h dose and P =.0011 for 60µg/kg/h dose; Study 202C: P =.0160 for 90µg/kg/h dose). Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14–20 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 Samantha Meltzer-Brody, MD, MPH, associate professor and director of UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders and primary investigator of the studies. “In these studies, brexanolone provided a profound and durable effect over the study period that could be an important step in potentially changing the way health care providers think about treating this disorder.”
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 [press release]. Cambridge, MA: Sage Therapeutics. Published November 9, 2017. Accessed November 16, 2017.
This article originally appeared on MPR