Marinus, With Ztalmy Approval, Takes First Step Into Seizure Disorder Market

Marinus Pharmaceuticals, Inc. has secured its first US Food and Drug Administration approval, and it is for Ztalmy (ganaxolone) for a rare pediatric seizure disorder, coming after a long development road and several failed clinical trials. The company announced the FDA approval of Ztalmy, an oral suspension, on 18 March for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients two years of age and older.

The initial approval is for an ultra-rare pediatric disorder that only affects about 75 to 100 newborns each year in the US, resulting in a relatively modest commercial opportunity. However, Marinus hopes to eventually expand ganaxolone oral and intravenous formulations to additional indications, treating a broader range of seizure disorders