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18 Apr 2016

Marinus Pharmaceuticals receives FDA Orphan Drug status for ganaxolone IV to treat status epilepticus

Marinus Pharmaceuticals, Inc, a biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to the intravenous (IV) formulation of its CNS-selective GABAA modulator, ganaxolone, for the treatment of status epilepticus. A phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of ganaxolone IV is expected to initiate in the first half of 2016.

Orphan Drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the US. The designation provides the drug developer with a seven-year period of US.marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

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