US2021213000A1PendingUtilityA1

Methods and compositions for treatment of epileptic disorders

80
Assignee: OVID THERAPEUTICS INCPriority: Aug 11, 2016Filed: Mar 30, 2021Published: Jul 15, 2021
Est. expiryAug 11, 2036(~10 yrs left)· nominal 20-yr term from priority
Inventors:Matthew During
A61P 25/08A61K 9/0019A61K 9/0053A61K 9/10A61K 31/57A61K 45/06A61K 31/573A61K 31/5513A61K 31/551A61K 31/55A61K 31/44A61K 31/437A61K 31/433A61K 31/27A61K 31/195A61K 2300/00A61K 31/7048A61K 31/4015A61K 31/4192A61K 31/165A61K 31/423A61K 31/197A61K 31/4535A61K 31/444A61K 31/515A61K 31/19A61K 31/53A61K 31/5517A61K 31/36A61K 31/325A61K 31/513A61K 31/4166A61P 43/00A61K 31/136
80
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Claims

Abstract

Use of allosteric modulators and/or gaboxadol for the treatment of epileptic disorders in a subject in need thereof.

Claims

exact text as granted — not AI-modified
1 - 5 . (canceled) 
     
     
         6 . A method of treating CDKL5 deficiency disorder comprising administering to a patient in need thereof a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the patient is administered up to 1,800 mg of ganaxolone per day wherein the composition provides reduction in the frequency of seizures. 
     
     
         7 . The method of  claim 6 , wherein the patient is administered ganaxolone two times daily. 
     
     
         8 . The method of  claim 6 , wherein the patient is administered ganaxolone three times daily. 
     
     
         9 . The method of  claim 6 , wherein the pharmaceutical composition is an oral capsule. 
     
     
         10 . The method of  claim 6 , wherein the pharmaceutical composition is an oral suspension. 
     
     
         11 . The method of  claim 6 , wherein the pharmaceutical composition comprises 200 mg ganaxolone. 
     
     
         12 . The method of  claim 6 , wherein the pharmaceutical composition comprises 400 mg ganaxolone. 
     
     
         13 . The method of  claim 6 , wherein the pharmaceutical composition comprises 450 mg ganaxolone. 
     
     
         14 . The method of  claim 6 , wherein the pharmaceutical composition comprises 600 mg ganaxolone. 
     
     
         15 . The method of  claim 6 , wherein the pharmaceutical composition comprises 900 mg ganaxolone. 
     
     
         16 . The method of  claim 6 , wherein the pharmaceutical composition comprises 1800 mg ganaxolone. 
     
     
         17 . The method of  claim 6 , wherein the patient is administered oral capsules comprising 200-600 mg ganaxolone twice daily. 
     
     
         18 . The method of  claim 6 , wherein the composition provides a Cmax less than 300 ng/ml. 
     
     
         19 . The method of  claim 6 , wherein the composition provides a Cmax less than 200 ng/ml. 
     
     
         20 . The method of  claim 6 , wherein the composition provides a Cmax less than 100 ng/ml. 
     
     
         21 . The method of  claim 6 , wherein the composition provides a Cmax between about 100 ng/ml and 200 ng/ml. 
     
     
         22 . The method of  claim 6 , wherein the composition provides a Cmax between about 200 ng/ml and 300 ng/ml. 
     
     
         23 . The method of  claim 6 , wherein the composition provides a dissolution of at least about 80% within the first 20 minutes of administration to the patient in need thereof. 
     
     
         24 . The method of  claim 6 , wherein the average reduction in seizure frequency is about 40%. 
     
     
         25 . The method of  claim 6 , wherein the average reduction in seizure frequency is about 40 to about 60%. 
     
     
         26 . The method of  claim 6 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax less than 200 ng/ml. 
     
     
         27 . The method of  claim 6 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml. 
     
     
         28 . The method of  claim 6 , wherein the average reduction in seizure frequency is about 40% to about 60% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml. 
     
     
         29 . A method of treating CDKL5 deficiency disorder comprising administering to a patient in need thereof three times daily a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the patient is administered up to 1,800 mg of ganaxolone per day wherein the composition provides reduction in the frequency of seizures. 
     
     
         30 . The method of  claim 29 , wherein the pharmaceutical composition is an oral capsule. 
     
     
         31 . The method of  claim 29 , wherein the pharmaceutical composition is an oral suspension. 
     
     
         32 . The method of  claim 29 , wherein the pharmaceutical composition comprises 200 mg ganaxolone. 
     
     
         33 . The method of  claim 29 , wherein the pharmaceutical composition comprises 400 mg ganaxolone. 
     
     
         34 . The method of  claim 29 , wherein the pharmaceutical composition comprises 450 mg ganaxolone. 
     
     
         35 . The method of  claim 29 , wherein the pharmaceutical composition comprises 600 mg ganaxolone. 
     
     
         36 . The method of  claim 29 , wherein the pharmaceutical composition comprises 900 mg ganaxolone. 
     
     
         37 . The method of  claim 29 , wherein the pharmaceutical composition comprises 1800 mg ganaxolone. 
     
     
         38 . The method of  claim 29 , wherein the patient is administered oral capsules comprising 200-600 mg ganaxolone twice daily. 
     
     
         39 . The method of  claim 29 , wherein the composition provides a Cmax less than 300 ng/ml. 
     
     
         40 . The method of  claim 29 , wherein the composition provides a Cmax less than 200 ng/ml. 
     
     
         41 . The method of  claim 29 , wherein the composition provides a Cmax less than 100 ng/ml. 
     
     
         42 . The method of  claim 29 , wherein the composition provides a Cmax between about 100 ng/ml and 200 ng/ml. 
     
     
         43 . The method of  claim 29 , wherein the composition provides a Cmax between about 200 ng/ml and 300 ng/ml. 
     
     
         44 . The method of  claim 29 , wherein the composition provides a dissolution of at least about 80% within the first 20 minutes of administration to the patient in need thereof. 
     
     
         45 . The method of  claim 29 , wherein the average reduction in seizure frequency is about 40%. 
     
     
         46 . The method of  claim 29 , wherein the average reduction in seizure frequency is about 40% to about 60%. 
     
     
         47 . The method of  claim 29 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax less than 200 ng/ml. 
     
     
         48 . The method of  claim 29 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml. 
     
     
         49 . The method of  claim 29 , wherein the average reduction in seizure frequency is about 40% to about 60% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml.

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