Marinus : FDA Grants Orphan Drug Designation To Ganaxolone For Lennox-Gastaut Syndrome Treatment

(RTTNews) - The U.S. Food and Drug Administration has granted orphan drug designation to ganaxolone for the treatment of Lennox-Gastaut syndrome (LGS), Marinus Pharmaceuticals Inc. (MRNS) said in a statement on Wednesday.

Marinus expects to initiate a multiple ascending dose study of a second generation ganaxolone formulation in the second quarter of 2023 and is planning to finalize the clinical program design for Lennox-Gastaut syndrome in the second half of this year.

Lennox-Gastaut syndrome is a severe form of epilepsy that begins in childhood with neurodevelopmental impairment and intractable atonic, tonic and generalized seizures.

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