Marinus Pharmaceuticals (NASDAQ: MRNS) this morning said that the FDA has granted Orphan Drug Designation to the company’s CNS-selective GABAA modulator, ganaxolone, for the treatment of Fragile X Syndrome, the most common genetic cause of autism, which is caused by a mutation in the FMR1 gene. This designation provides Marinus with a seven-year period of U.S. 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 filing fees. “We are pleased to receive Orphan Drug Designation from the FDA for ganaxolone in Fragile X Syndrome … This designation underscores the significant unmet medical need for children suffering from a genetic mutation that causes autism-like symptoms including anxiety, mood swings and attention deficit,” Christopher M. Cashman, Marinus Pharmaceuticals CEO, stated in the news release.
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About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, demonstrated efficacy and safety and convenient dosing, to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders. Ganaxolone is a CNS-selective GABAA modulator that acts on a well-characterized target in the brain known to have both anti-seizure and anti-anxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus is currently evaluating ganaxolone in orphan pediatric indications for the treatment of genetic seizure and behavior disorders, and preparing to initiate Phase 2 studies in status epilepticus, an orphan indication, and postpartum depression. For more information visit www.marinuspharma.com.
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