Ztalmy®

Drug - Ztalmy® (ganaxolone) [Marinus Pharmaceuticals, Inc.]

March 2025

Therapeutic Area - Anticonvulsants

Initial approval criteria

Patient is at least 2 years of age; AND
Patient has a diagnosis of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) confirmed with genetic testing; AND
Ztalmy will be prescribed by or in consultation with a neurologist; AND
Patient will avoid concomitant therapy with moderate or strong CYP450 inducers or if concomitant therapy is unavoidable, dose adjustments will be considered; AND
Initial approval will be for 6 months

Prescriber attests to stabilization of disease or reduction in seizure frequency from baseline; AND
Patient has not experienced any treatment-limiting adverse effects (e.g., suicidal thoughts or behavior); AND
Renewal approval will be for 12 months

Patient weighing 28kg or less: 63mg/kg/day (in 3 divided doses)
- Patient’s weight (in kg) must be provided at time of request
Patient weighing over 28kg: 1800mg daily (in 3 divided doses)

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