# US 12,109,201 B2 · Methods and compositions for treatment of epileptic disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,201 B2 - Document ID: US12109201B2 - Status: Granted - Kind: B2 - Application number: 17/843,028 - Filed: 2022-06-17 - Published: 2022-10-13 - Granted: 2024-10-08 - Earliest claimed: 2016-08-11 - Assignees: Ovid Therapeutics Inc. - Applicants: Ovid Therapeutics, Inc. - Inventors: Matthew During - Web page: https://patentgrep.com/patent/US12109201B2 ## CPC - A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline - 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 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide - A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60) - A61K 31/195: having an amino group - A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205) - A61K 31/27: of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine - A61K 31/325: Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof (thiurams A61K31/145) - A61K 31/36: Compounds containing methylenedioxyphenyl groups, e.g. sesamin - A61K 31/4015: having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide - A61K 31/4166: having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin - A61K 31/4192: 1,2,3-Triazoles - A61K 31/423: condensed with carbocyclic rings - A61K 31/433: Thidiazoles - A61K 31/44: Non condensed pyridines; Hydrogenated derivatives thereof - A61K 31/444: containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone - A61K 31/4535: containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen - A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine - A61K 31/515: Barbituric acids; Derivatives thereof, e.g. sodium pentobarbital - A61K 31/53: having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine (melarsoprol A61K31/555 {; with four nitrogen atoms A61K31/495}) - A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole - A61K 31/5513: 1,4-Benzodiazepines, e.g. diazepam {or clozapine} - A61K 31/5517: condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam - A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone - A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 25/08: Antiepileptics; Anticonvulsants - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - 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 Use of allosteric modulators and/or gaboxadol for the treatment of epileptic disorders in a subject in need thereof. ## Claims ### Claim 1 A method of treating status epilepticus comprising administering to a human patient diagnosed with status epilepticus an effective amount of ganaxolone, wherein the effective amount of ganaxolone is administered by a combination of a first intravenous dose and a second dose continuous infusion, and wherein the effective amount provides a consistent ganaxolone plasma concentration of about 500 ng/ml and provides improvement of at least one symptom of the human patient for at least 8 hours after administration. ### Claim 2 (depends on 1) The method of claim 1, wherein the first dose is an intravenous injection. ### Claim 3 (depends on 1) The method of claim 1, wherein the first dose is an intravenous infusion. ### Claim 4 (depends on 1) The method of claim 1, wherein the first dose is characterized by an immediate release profile and wherein the second dose is characterized by and extended release profile. ### Claim 5 (depends on 1) The method of claim 1, wherein the administration of the first and second doses occurs within 2 hours. ### Claim 6 (depends on 1) The method of claim 1, wherein the administration of the first and second doses occurs within 30 minutes. ### Claim 7 (depends on 1) The method of claim 1, wherein the method provides improvement of at least one symptom the human patient for more than 12 hours after administration. ### Claim 8 (depends on 1) The method of claim 1, wherein the method provides improvement of at least one symptom the human patient for more than 24 hours after administration. ### Claim 9 (depends on 1) The method of claim 1, wherein the method provides improvement of at least one symptom the human patient for 8 hours to 24 hours after administration. ### Claim 10 (depends on 1) The method of claim 1, wherein the first dose comprises about 1 mg to about 30 mg ganaxolone. ### Claim 11 (depends on 1) The method of claim 1, wherein the first dose comprises about 30 mg ganaxolone. ### Claim 12 (depends on 1) The method of claim 1, wherein the total amount of ganaxolone administered to the human patient in a 24-hour period is 1 mg to 2500 mg. ### Claim 13 (depends on 1) The method of claim 1, wherein the total amount of ganaxolone administered to the human patient in a 24-hour period is less than about 1500 mg. ### Claim 14 (depends on 1) The method of claim 1, wherein the total amount of ganaxolone administered to the human patient in a 24-hour period is less than about 1000 mg. ### Claim 15 A method of treating status epilepticus comprising administering to a human patient diagnosed with status epilepticus an effective amount of ganaxolone, wherein the effective amount of ganaxolone is administered by a combination of a first intravenous injection and a second dose continuous infusion, and wherein the effective amount provides a consistent ganaxolone plasma concentration of at least about 500 ng hr/ml and provides improvement of at least one symptom of the human patient for 8 hours to 12 hours after administration. ### Claim 16 (depends on 15) The method of claim 15, wherein the first dose is characterized by an immediate release profile and wherein the second dose is characterized by and extended release profile. ### Claim 17 (depends on 15) The method of claim 15, wherein the administration of the first and second doses occurs within 2 hours. ### Claim 18 (depends on 15) The method of claim 15, wherein the administration of the first and second doses occurs within 30 minutes. ### Claim 19 A method of treating status epilepticus comprising administering to a human patient diagnosed with status epilepticus a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition is administered intravenously to provide about 500 mg to 1000 mg/day ganaxolone and improves at least one symptom for more than 12 hours after administration of the pharmaceutical composition to the patient. ### Claim 20 (depends on 19) The method of claim 19 wherein the composition provides improvement of next day functioning of the patient after administration for more than about 8 hours. ### Claim 21 (depends on 19) The method of claim 19 wherein administration of the composition provides a plasma concentration of about 500 ng/ml for more than about 8 hours.