3 August 2021 -  Marinus Pharmaceuticals today announced the submission of a new drug application to the FDA for the use of its lead product candidate ganaxolone, to treat seizures associated with CDKL5 deficiency disorder, a rare, genetic epilepsy. 

The new drug application is supported by data from the Phase 3 Marigold trial, a double-blind placebo-controlled trial in which 101 patients treated with ganaxolone showed a 30.7% median reduction in 28-day major motor seizure frequency, compared to a 6.9% reduction for those receiving placebo, achieving the trial’s primary outcome (p=0.0036).

Read Marinus Pharmaceuticals press release