Published Date : Sep 10, 2015
Marinus Pharmaceuticals Inc., a U.S.-based biopharma company that develops innovative therapeutics for the treatment of epilepsy and neuropsychiatric diseases has announced the successful completion of the End-of-Phase two meeting with the U.S. FDA on Sep 09th, 2015. The meeting was aimed at obtaining the feedback of the FDA on the clinical as well as non-clinical programs for the registration of ganaxolone that would be used to treat partial onset seizures in adults.
The CEO of Marinus pharmaceuticals, Mr. Christopher M. Cashman stated that they are very happy with the positive response of the FDA and they believe that the clinical development and registration strategy for ganaxolone is going to support an NDA submission. He further added that they are looking forward to completing their on-going Phase three clinical trial in adults suffering from partial onset seizures and will be starting a 2nd phase three clinical trial in the year 2016.
The FDA approved the Marinus’ plans at the meeting to support the registration of ganaxolone for the treatment of partial onset seizures in adults. The strategy of Marinus includes an additional registration study of phase three. The population, design, and primary endpoint for both the clinical study, i.e., ongoing and planned 2nd phase three are approved by the FDA. The pharma company plans to submit the protocol of the 2nd phase three study very soon.
The 2nd phase three clinical trial is likely to be a global, double-blind, randomized, placebo-controlled research, which is designed to assess the efficiency and safety of ganaxolone in adults, who are equal or more than 17 years of age and have been detected with partial onset seizures.