Monday, Marinus Pharmaceuticals Inc ( MRNS ) announced topline results from the Phase 3 RAISE trial evaluating the safety and efficacy of intravenous (IV) ganaxolone for refractory status epilepticus (RSE).

In the RAISE trial, patients with RSE who failed at least two antiseizure medications were randomized to IV ganaxolone or placebo in addition to standard-of-care treatment.

The intent-to-treat population comprised 96 patients, 49 in the IV ganaxolone and 47 in the placebo arm.

Related: Analysts Question Commercial Viability of Marinus’ IV Ganaxolone After Interim Analysis Miss.

Topline data demonstrated that:

A statistically significant proportion of patients had status epilepticus cessation within 30 minutes of initiating IV ganaxolone compared to placebo: 80% vs. 13%, respectively (p