# US 11,110,100 B2 · Ganaxolone for use in treatment of status epilepticus > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,110,100 B2 - Document ID: US11110100B2 - Status: Granted - Kind: B2 - Application number: 17/186,569 - Filed: 2021-02-26 - Published: 2021-06-24 - Granted: 2021-09-07 - Earliest claimed: 2019-08-05 - Assignees: Marinus Pharmaceuticals - Applicants: Marinus Pharmaceuticals, Inc. - Inventors: David Czekai; Maciej Gasior; Lorianne Masuoka; Julia Tsai; Joseph Hulihan; Alex Aimetti - Web page: https://patentgrep.com/patent/US11110100B2 ## CPC - A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 47/40: Cyclodextrins; Derivatives thereof - A61P 25/08: Antiepileptics; Anticonvulsants - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE. ## Claims ### Claim 1 A method of treating status epilepticus (SE), comprising administering to a subject in need thereof an effective amount of ganaxolone to suppress SE, wherein the effective amount of ganaxolone is administered as an intravenous bolus plus continuous infusion to produce and maintain a ganaxolone plasma concentration of about 500 ng/ml to about 1000 ng/ml for about 8 hours to about 12 hours. ### Claim 2 (depends on 1) The method of claim 1, wherein the intravenous bolus comprises about 5 mg to about 40 mg of ganaxolone. ### Claim 3 (depends on 2) The method of claim 2, wherein the intravenous bolus comprises about 30 mg of ganaxolone. ### Claim 4 (depends on 1) The method of claim 1, wherein the continuous intravenous infusion comprises infusion of about 20 mg of ganaxolone per hour to about 80 mg of ganaxolone per hour. ### Claim 5 (depends on 4) The method of claim 4, wherein about 80 mg of ganaxolone per hour are infused into the subject at the initiation of the continuous intravenous infusion and for at least about 2 hours thereafter. ### Claim 6 (depends on 5) The method of claim 5, wherein the amount of ganaxolone infused into the subject by the continuous intravenous infusion is decreased from about 80 mg per hour to about 40 mg per hour after about 2 hours. ### Claim 7 (depends on 6) The method of claim 6, wherein the 40 mg per hour continuous intravenous infusion is administered for about 6 hours to about 10 hours. ### Claim 8 (depends on 7) The method of claim 7, further comprising continuing to administer ganaxolone by the continuous intravenous infusion, wherein the amount of ganaxolone infused is decreased to about 20 mg per hour. ### Claim 9 (depends on 8) The method of claim 8, wherein the 20 mg per hour continuous intravenous infusion is administered for about 12 hours to about 24 hours. ### Claim 10 (depends on 2) The method of claim 2, wherein a continuous intravenous infusion of ganaxolone is initiated periprocedurally with the intravenous bolus and the continuous intravenous infusion comprises: a) an infusion of about 80 mg ganaxolone per hour for about 2 hours, then b) an infusion of about 40 mg ganaxolone per hour for about 6 hours to about 10 hours, then c) an infusion of about 20 mg ganaxolone per hour for about 12 hours to about 24 hours. ### Claim 11 (depends on 1) The method of claim 1, wherein the intravenous bolus produces a ganaxolone plasma concentration in the subject of about 500 ng/ml to about 1000 ng/ml. ### Claim 12 (depends on 10) The method of claim 10, wherein the intravenous bolus is administered to the subject for about 1 minute to about 5 minutes. ### Claim 13 (depends on 10) The method of claim 10, further comprising a taper period of about 12 hours. ### Claim 14 (depends on 1) The method of claim 1, wherein the subject has refractory status epilepticus. ### Claim 15 (depends on 1) The method of claim 1, wherein the amount of ganaxolone infused into the subject by the continuous infusion is decreased at least once while the ganaxolone plasma concentration of about 500 ng/ml to about 1000 ng/ml is maintained. ### Claim 16 (depends on 1) The method of claim 1, wherein the total daily dose of ganaxolone administered is from about 500 mg to about 900 mg. ### Claim 17 (depends on 15) The method of claim 15, further comprising continuing the intravenous infusion and reducing the amount of ganaxolone that is administered. ### Claim 18 (depends on 10) The method of claim 10, wherein the subject has refractory status epilepticus. ### Claim 19 (depends on 17) The method of claim 17, wherein the subject has refractory status epilepticus. ### Claim 20 (depends on 3) The method of claim 3, wherein a continuous intravenous infusion of ganaxolone is initiated periprocedurally with the intravenous bolus and the continuous intravenous infusion comprises: a) an infusion of about 80 mg ganaxolone per hour for about 2 hours, then b) an infusion of about 40 mg ganaxolone per hour for about 6 hours to about 10 hours, then c) an infusion of about 20 mg ganaxolone per hour for about 12 hours to about 24 hours. ### Claim 21 (depends on 20) The method of claim 20, wherein the subject has refractory status epilepticus.