Brexanolone

(Zulresso®)

Brexanolone

Drug updated on 10/29/2024

Dosage FormInjection (intravenous; 100 mg/20 mL [5 mg/mL])
Drug ClassNeuroactive 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.

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Summary
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  • 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.