Drug updated on 10/29/2024
Dosage Form | Injection (intravenous; 100 mg/20 mL [5 mg/mL]) |
Drug Class | Neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulators |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of postpartum depression (PPD) in patients 15 years and older.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Brexanolone demonstrated significant effectiveness in reducing postpartum depression (PPD) symptoms, with a systematic review indicating improvements in Hamilton Rating Scale for Depression (HAMD-17) scores at hour 60 and day 30 compared to placebo, as well as a higher overall clinical benefit rate compared to other treatments; it was particularly effective in pregnant, postpartum, or reproductive-age women with mental health disorders.
- The Surface Under the Cumulative Ranking Curve (SUC) rankings for treatment effectiveness placed estradiol highest (94.3%), followed by brexanolone (46.91%) and sertraline, with brexanolone showing notable improvements in response and remission rates, including a risk ratio (RR) of 2.24 for response compared to placebo.
- While brexanolone was effective, it had higher early dropout rates and an increased risk of sedation or somnolence (5% vs. 0% for placebo), indicating potential tolerability issues, especially in the targeted population of postpartum women.
- Brexanolone was associated with a higher early dropout rate compared to most other antidepressants, indicating potential tolerability issues; specifically, the dropout rate due to safety concerns was noted, although the exact percentage was not specified.
- The evidence highlights that brexanolone is effective in reducing depressive symptoms specifically in pregnant, postpartum, or reproductive-age women with mental health disorders, with particular assessments for those experiencing depression onset in the third trimester or postpartum period; sertraline is also noted to potentially improve response and remission in postpartum women, though with less certainty in the data.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zulresso (brexanolone) Prescribing Information. | 2024 | Sage Therapeutics Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Comparative efficacy and acceptability of pharmacotherapies for postpartum depression: A systematic review and network meta-analysis | 2022 | Frontiers in Pharmacology |
Investigational Drugs for the Treatment of Depression (Part 1): Monoaminergic, Orexinergic, GABA-Ergic, and Anti-Inflammatory Agents | 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 (US) |
Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making | 2021 | Journal of Women's Health |