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

 
• By Jessica Merrill

The company will launch Ztalmy for an ultra-rare pediatric seizure disorder but hopes to expand to larger indications in the future. CEO Scott Braunstein talks to Scrip about the launch.

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Marinus has reached its commercial start • Source: Alamy

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...

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