Drug updated on 9/4/2024
| Dosage Form | Suspension (oral; 50 mg/mL) |
| Drug Class | Neuroactive steroid gamma-aminobutyric acid modulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
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Summary
- Ztalmy (ganaxolone) is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Ganaxolone was associated with a significant reduction in mean seizure frequency in a meta-analysis of 659 patients from four RCTs, with a risk ratio (RR) of 1.60 (95% CI: 1.02-2.49, p = 0.04, I² = 30%).
- No statistically significant difference was found in the percentage of seizure-free days between ganaxolone and placebo (p = 0.36).
- The occurrence of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to drug discontinuation did not show significant differences between the ganaxolone and placebo groups (p > 0.05).
- No specific safety concerns or adverse effects were identified in any particular population types or subgroups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ztalmy (ganaxolone) prescribing information. | 2022 | Marinus Pharmaceuticals, Inc., Radnor, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: a meta-analysis from randomized controlled trials. | 2022 | Journal of the International League Against Epilepsy |