Marinus Pharmaceuticals Gets FDA Orphan Drug Status For Its Ganaxolone IV

Marinus Pharmaceuticals Inc

revealed that the FDA has granted Orphan Drug Designation to its intravenous formation of its CNS-selective GABAA modulator, ganaxolone, for status epilepticus treatment. According to the company, a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of ganaxolone IV is predicted to be commenced before the end of the first half of the current year. Marinus Pharmaceuticals CEO, Christopher Cashman, said that "Status epilepticus is a life-threatening condition, associated with high mortality and if not treated immediately, can result in brain damage, cognitive impairment and death". He added that "We are pleased to receive the Orphan Drug Designation for ganaxolone IV in this difficult to treat seizure disorder with limited treatment options." The company stated that the FDA's approval was for the novel drugs or biologics that treat a rare disease or condition affecting less than 200,000 patients in the U.S. The drug firm said that the designation provided it with a seven-year period of marketing exclusivity in the America, as well as, tax credits for clinical research costs. Shares of the company closed with a loss of 5.3% on Thursday.