Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 100 mg/20 mL [5 mg/mL]) |
| Drug Class | Neuroactive steroid gamma-aminobutyric acid modulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of postpartum depression (PPD) in patients 15 years and older.
Summary
- Brexanolone (Zulresso) is indicated for the treatment of postpartum depression (PPD) in individuals 15 years and older. It has demonstrated significantly higher percentages of patients achieving response and remission rates in the Hamilton Depression Rating Scale (HAM-D) for PPD when compared to placebo, indicating robust efficacy.
- The information was synthesized from four systematic reviews/meta-analyses documents on Zulresso's use for treating PPD. However, only three studies were reviewed due to an error encountered during one document retrieval.
- A single infusion of brexanolone showed a rapid antidepressant effect starting after 24 hours, peaking at 36 and 60 hours, and lasting up to seven days, showcasing its potential for providing quick relief from PPD symptoms.
- In comparison with other treatments for PDD such as estradiol or paroxetine based on cumulative probability rankings from a network meta-analysis involving eleven studies with nine hundred forty-four participants; brexanolone may not be the most effective option available despite being among the top treatments.
- Concerning safety and tolerability; while some individuals discontinued treatment due to reasons suggesting concerns about its tolerability, adverse reactions at severe levels were not significantly greater than those experienced by placebo users. Moreover, early dropouts suggest that acceptance might be limited potentially due to the mode of administration or side effects impacting their decision to continue treatment.
- Studies primarily focused on women suffering from postpartum depression without detailed subgroup analyses based on demographic factors. Hence, data are mostly applicable to this population without specific indications of differential effects on subpopulations available for the time period under review.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zulresso (brexanolone) Prescribing Information | 2022 | Sage Therapeutics Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| The efficacy and safety of some new GABAkines for treatment of depression: a systematic review and meta-analysis from randomized controlled trials. | 2023 | Psychiatry Research |
| Comparative efficacy and acceptability of pharmacotherapies for postpartum depression: a systematic review and network meta-analysis. | 2022 | Frontiers in Pharmacology |
| Maternal, fetal, and child outcomes of mental health treatments in women: a systematic review of perinatal pharmacologic interventions. | 2021 | Agency for Healthcare Research and Quality |
| Brexanolone for postpartum depression: a meta-analysis of randomized controlled studies. | 2019 | Psychiatry Research |