Location
Suwanee, GA
Start Date
11-5-2023 1:00 PM
End Date
11-5-2023 4:00 PM
Description
Introduction: With the recognition of postpartum depression as a distinct medical condition since the release of the 2013 DSM-V, there simultaneously arose a need for therapy. As of March 2019, brexanolone became the first FDA approved medication indicated for the treatment of postpartum depression. The purpose of this review is to consolidate and present the safety and efficacy data of a new treatment option for postpartum depression.
Methods: A date range was specified of January 2015 to May 2022 with the last search being conducted June 28, 2022. Cochrane, PubMed, Embase, and Google Scholar were utilized to identify appropriate trials. The terms and phrases searched were, “postpartum depression”, “pregnancy”, “FDA approved”, “new therapy”, “new treatment”, “efficacy and safety”, and “phase 3 trial”. Studies were excluded upon meeting any of the following criteria: phase 1 or 2, lacking FDA approval, non-pharmaceutical, or no indication for postpartum depression. After reviewing 41 entries, two phase three trials were selected, investigated, and presented.
In study one, 138 women were randomized to receive either brexanolone 90µg/kg/hr (BRX90) or placebo continuously over 60 hours. Inclusion criteria were age between 18-45 years, Hamilton Rating Scale for Depression (HAM-D) score of ≥ 26, negative pregnancy test, at least one major depressive episode no earlier than the third trimester or no later than 4 weeks postpartum, and ≤ 6 months postpartum overall. Exclusion criteria were suicide attempt during the current postpartum period, bipolar disorder, schizophrenia, or anemia.
Results: The primary efficacy endpoint measured in both studies was least squares (LS) mean change in HAM-D score from baseline at 60 hours. In study one, the LS mean change in HAM-D score was -17.7 points (BRX90), -19.5 points (BRX60), and -14.0 points (placebo). In study 2, the LS mean change was -14.6 (BRX90) and -12.1 (placebo). Secondary efficacy endpoints were HAM-D total score and LS mean change from baseline. These statistical data were further used to determine the LS mean difference between brexanolone and placebo. The LS mean difference between BRX90 and placebo was -3.8 points (95 percent CI, -7.6 to 0.0; P equals 0.0481) while in BRX60 it was -5.6 points (95 percent CI, -9.5 to -1.8; P equals 0.0044). In study 2, there was a LS mean difference of 0.5 points in the BRX90 group (95 percent CI, -2.0 to 3.1; P equals 0.6710).
Discussion/Conclusion: In these two clinical trials, brexanolone was shown to be more efficacious than placebo at decreasing depressive symptoms in postpartum women; particularly when treated with 60µg/kg/hr. Improvement in mood was observed in a couple hours with persistence up to 30 days. For those patients requiring rapid relief of symptoms, this form of treatment could prove to be vital. However, the practicality of a 60-hour continuous infusion is still questionable and would likely require careful patient-clinician consideration. Further investigations should be conducted to explore this aspect of brexanolone’s use as well as its long-term safety and efficacy outcomes.
Embargo Period
6-27-2023
Safety and efficacy of brexanolone as a novel treatment option for postpartum depression: a systematic review.
Suwanee, GA
Introduction: With the recognition of postpartum depression as a distinct medical condition since the release of the 2013 DSM-V, there simultaneously arose a need for therapy. As of March 2019, brexanolone became the first FDA approved medication indicated for the treatment of postpartum depression. The purpose of this review is to consolidate and present the safety and efficacy data of a new treatment option for postpartum depression.
Methods: A date range was specified of January 2015 to May 2022 with the last search being conducted June 28, 2022. Cochrane, PubMed, Embase, and Google Scholar were utilized to identify appropriate trials. The terms and phrases searched were, “postpartum depression”, “pregnancy”, “FDA approved”, “new therapy”, “new treatment”, “efficacy and safety”, and “phase 3 trial”. Studies were excluded upon meeting any of the following criteria: phase 1 or 2, lacking FDA approval, non-pharmaceutical, or no indication for postpartum depression. After reviewing 41 entries, two phase three trials were selected, investigated, and presented.
In study one, 138 women were randomized to receive either brexanolone 90µg/kg/hr (BRX90) or placebo continuously over 60 hours. Inclusion criteria were age between 18-45 years, Hamilton Rating Scale for Depression (HAM-D) score of ≥ 26, negative pregnancy test, at least one major depressive episode no earlier than the third trimester or no later than 4 weeks postpartum, and ≤ 6 months postpartum overall. Exclusion criteria were suicide attempt during the current postpartum period, bipolar disorder, schizophrenia, or anemia.
Results: The primary efficacy endpoint measured in both studies was least squares (LS) mean change in HAM-D score from baseline at 60 hours. In study one, the LS mean change in HAM-D score was -17.7 points (BRX90), -19.5 points (BRX60), and -14.0 points (placebo). In study 2, the LS mean change was -14.6 (BRX90) and -12.1 (placebo). Secondary efficacy endpoints were HAM-D total score and LS mean change from baseline. These statistical data were further used to determine the LS mean difference between brexanolone and placebo. The LS mean difference between BRX90 and placebo was -3.8 points (95 percent CI, -7.6 to 0.0; P equals 0.0481) while in BRX60 it was -5.6 points (95 percent CI, -9.5 to -1.8; P equals 0.0044). In study 2, there was a LS mean difference of 0.5 points in the BRX90 group (95 percent CI, -2.0 to 3.1; P equals 0.6710).
Discussion/Conclusion: In these two clinical trials, brexanolone was shown to be more efficacious than placebo at decreasing depressive symptoms in postpartum women; particularly when treated with 60µg/kg/hr. Improvement in mood was observed in a couple hours with persistence up to 30 days. For those patients requiring rapid relief of symptoms, this form of treatment could prove to be vital. However, the practicality of a 60-hour continuous infusion is still questionable and would likely require careful patient-clinician consideration. Further investigations should be conducted to explore this aspect of brexanolone’s use as well as its long-term safety and efficacy outcomes.