Brexanolone injection (BRX) is a positive allosteric modulator of γ-aminobutyric-acid type A (GABAA) receptors being investigated for the treatment of moderate to severe post-partum depression.
In study 1 (n=138), at 60 h, the least-squares (LS) mean reduction in HAM-D total score from baseline was 19.5 points in the BRX60 group and 17.7 points in the BRX90 group compared with 14.0 points for placebo (difference −5.5; 95% CI −8.8 to −2.2; p=0·0013 for the BRX60 group; −3.7; −6.9 to −0.5; p=0.0252 for BRX90 group).
In study 2 (n=108), at 60 h, the LS mean reduction in HAM-D total score from baseline was 14.6 points in the BRX90 group compared with 12.1 points for placebo (difference −2.5; −4.5 to −0.5; p=0.0160).
A New Drug Application has been submitted to the US FDA for brexanolone for this indication.