Marinus Reports Positive End-of-Phase 2 Meeting With FDA For Ganaxolone

(RTTNews) - Marinus Pharmaceuticals, Inc. (MRNS) Wednesday announced the successful completion of an End-of-Phase 2 meeting with the Food and Drug Administration.

The objective of the meeting was to obtain FDA feedback on the nonclinical and clinical programs to support registration of ganaxolone for the adjunctive treatment of focal onset seizures in adults.

At the meeting, the FDA agreed with Marinus on its planned path to support registration of ganaxolone for adjunctive treatment of focal onset seizures. This, among other expected preclinical and clinical studies, includes a single additional Phase 3 registration study.

Marinus and FDA are in agreement on the design, population and primary endpoint for the ongoing and planned second Phase 3 clinical study. Marinus plans to submit the protocol of the second Phase 3 study to the FDA for a Special Protocol Assessment.

The second Phase 3 clinical trial is expected to be a global, randomized, double-blind, placebo-controlled study, designed to assess the efficacy and safety of ganaxolone in adults, 17 years or older, diagnosed with focal onset seizures.

The planned primary endpoint for the study will be percent change in seizure frequency per 28 days relative to baseline.

Marinus is currently conducting a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial of ganaxolone in around 300 adults with drug-resistant focal onset seizures.

The primary endpoint of the study is percent change in seizure frequency per 28 days relative to baseline. Top-line data from the study are expected in the first quarter of 2016.