Claims for Patent: 10,940,156

Summary for Patent: 10,940,156

Title:	Neuroactive steroids, compositions, and uses thereof
Abstract:	Described herein are methods of treating a disorder, e.g., tremor, e.g., essential tremor; depression, e.g., postpostum depression; and anxiety disorder, the method comprising administering to a human subject suffering from a disorder, e.g., tremor, e.g., essential tremor; depression, e.g., postpostum depression, an anxiety disorder with a neuroactive steroid or a composition comprising a neuroactive steroid (e.g., pregnanolone, allopregnanolone, alphadalone, ganaxolone, or alphaxolone).
Inventor(s):	Stephen Jay Kanes, Helen Colquhoun
Assignee:	Sage Therapeutics Inc
Application Number:	US16/718,430
Patent Claims:	1. A method for treating post-partum depression in a human subject in need thereof, the method comprising administering allopregnanolone at a dosing regimen over a time period of about 60 hours, wherein the dosing regimen comprises a continuous infusion of: 30 μg/kg/hour of allopregnanolone from about hour 0 to about hour 4; 60 μg/kg/hour of allopregnanolone from about hour 4 to about hour 24; 90 μg/kg/hour of allopregnanolone from about hour 24 to about hour 52; 60 μg/kg/hour of allopregnanolone from about hour 52 to about hour 56; and 30 μg/kg/hour of allopregnanolone from about hour 56 to about hour 60. 2. The method of claim 1, wherein allopregnanolone is in a sterile aqueous solution comprising allopregnanolone and sulfobutylether-β-cyclodextrin. 3. The method of claim 2, wherein the sterile aqueous solution is buffered with citrate. 4. The method of claim 3, wherein the sterile aqueous solution comprises about 0.1 mg/mL to about 10 mg/mL of allopregnanolone. 5. The method of claim 4, wherein the sterile aqueous solution comprises about 0.1 mg/mL to about 5 mg/mL of allopregnanolone. 6. The method of claim 5, wherein the sterile aqueous solution comprises about 1 mg/mL of allopregnanolone. 7. The method of claim 3, wherein the sterile aqueous solution comprises about 1% to about 30% by weight of sulfobutylether-β-cyclodextrin per volume of sterile aqueous solution. 8. The method of claim 7, wherein the sterile aqueous solution comprises about 1% to about 15% by weight of sulfobutylether-β-cyclodextrin per volume of sterile aqueous solution. 9. The method of claim 8, wherein the sterile aqueous solution comprises about 1% to about 5% by weight of sulfobutylether-β-cyclodextrin per volume of sterile aqueous solution. 10. The method of claim 9, wherein the sterile aqueous solution comprises about 5% by weight of sulfobutylether-β-cyclodextrin per volume of sterile aqueous solution.