PMH2 BREXANOLONE INJECTION IN POSTPARTUM DEPRESSION: SUSTAINED REMISSION, SUSTAINED RESPONSE, AND NUMBER NEEDED TO TREAT

Abstract

The Food and Drug Administration recently approved brexanolone injection (BRX), a neuroactive steroid chemically identical to allopregnanolone, for the treatment of postpartum depression. A prespecified integrated analysis of randomized placebo-controlled trials of BRX demonstrated significantly greater least-squared mean reduction in Hamilton Rating Scale for Depression (HAM-D) total score and greater HAM-D remission and response at 60 hours versus placebo (PBO). This study further evaluated sustained remission and response through trial follow-up (Day 30) and reported the number needed to treat (NNT) to achieve an additional HAM-D remission or response. The integrated efficacy dataset was used. NNTs were calculated at Hour 60 using the proportion of HAM-D remitters (score £7) and responders (³50% reduction from baseline) randomized to BRX vs PBO. Corresponding analyses were performed for sustained remission and response. Hour 60 remitters/responders were considered sustained if criteria were also met at both Day 7 and Day 30. A significantly higher proportion of patients achieved HAM-D remission with BRX vs PBO at Hour 60 (50% vs 26%; p<0.001; NNT=5) and sustained HAM-D remission through Day 30 (32% vs 16%; p<0.05; NNT=7). A significantly higher proportion of patients achieved HAM-D response with BRX vs PBO at Hour 60 (74% vs 56%, p<0.01, NNT=6) and a numerically higher proportion sustained HAM-D response through Day 30 (50% vs 37%, p<0.065, NNT=8). A higher proportion of BRX-treated patients achieved remission and response vs PBO at Hour 60. Twice as many BRX-treated patients achieved sustained remission through 4 weeks after end of treatment (end of trial follow-up), compared to PBO. Single-digit NNTs for both rapid (Hour 60) and sustained (through Day 30) outcomes support the robustness of the effect. The most common adverse events (≥10%) with BRX were headache, dizziness, and somnolence.