US-based Sage Therapeutics has reported an integrated analysis of three clinical trials that investigated its brexanolone injection for the treatment of postpartum depression (PPD).
Brexanolone is an allosteric modulator of synaptic and extra-synaptic GABAA receptors.
Allosteric modulation of neurotransmitter receptor is known to cause different degrees of desired activity, instead of total activation or inhibition of the receptor.
The results, which have been published in The Lancet, showed a significant and clinically meaningful decrease in HAM-D total score, a depression severity measure, compared with placebo.
This reduction was observed after treatment with 90µg/kg/h brexanolone injection at the primary timepoint of 60 hours.
The trials also demonstrated statistically significant improvement in HAM-D total score within 24 hours of treatment initiation. The treatment response sustained through the 30-day follow-up.
During these studies, the most common adverse events were found to be headache, dizziness and somnolence.
Sage Therapeutics chief medical officer Steve Kanes said: “These data show a profound, rapid and durable reduction in PPD symptoms was achieved during the study period among the majority of participants receiving brexanolone.
“We believe these results validate our clinical approach to drug development and our efforts to bring treatments to areas of significant unmet need.”
The integrated analysis involved two Phase III and one Phase II double-blind, randomised, placebo-controlled trials completed last year.
Brexanolone injection is said to have shown similar HAM-D total score decrease results in patients with and without a concomitant antidepressant use.
When compared to placebo, brexanolone injection demonstrated higher remission rates and response at hour 60.
Sage said that the US Food and Drug (FDA) has conditionally accepted the proprietary name Zulresso for intravenous brexanolone formulation.