BRANFORD, Conn., March 3 /PRNewswire/ -- Marinus Pharmaceuticals, Inc. today announced that it met its primary endpoint for its Phase 2 clinical trial investigating the safety and efficacy of ganaxolone as adjunctive therapy in adults with partial onset seizures, a type of epilepsy. In this trial, ganaxolone demonstrated a statistically significant reduction in seizures versus placebo. Efficacy was seen in the first week of dosing. Ganaxolone was also found to be safe and well-tolerated in this population adding to the safety database of more than 950 subjects.
Partial seizures are episodes of abnormal electrical activity in the temporal lobe of the brain, an area near the side of the head, resulting in unconsciousness with symptoms of decreased responsiveness and decreased awareness of self and surroundings. Partial seizures occur in about 35 percent of people with epilepsy.
"This is a major milestone validating the effectiveness of ganaxolone, as a novel first in class anticonvulsant drug. Ganaxolone is the only neurosteroid in clinical development and is a unique GABA modulator that will expand the armamentarium of drugs available to treat epilepsy. The novel mechanism of action and excellent safety profile of this compound also has the potential to specifically address the unique needs of women with epilepsy," commented John Krayacich, president and CEO of Marinus Pharmaceuticals, Inc. "We look forward to continuing the development of ganaxolone for epilepsy as well as exploring its unique mechanism of action in other central nervous system (CNS) indications such as post traumatic stress disorder and postpartum depression. We believe patients with these and other CNS disorders may benefit from this unique compound."
The Phase 2 trial was a randomized, double-blind, placebo-controlled trial evaluating ganaxolone as add-on therapy for adults with partial onset seizures, who continued to have seizur
|SOURCE Marinus Pharmaceuticals, Inc.|
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