IP Library Granted Patent US 10,940,156
Granted Patent B2
US 10,940,156 · App. 16/718,430 · Granted Mar 9, 2021

Neuroactive steroids, compositions, and uses thereof

Inventors: Stephen Jay Kanes (Brynlawn, PA); Helen Colquhoun (Arlington, MA)
Assignee: Sage Therapeutics, Inc.
A61K31/57A61K9/0019A61K9/08A61K47/40A61P25/24
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,940,156
App. No.
16/718,430
Granted
Mar 9, 2021
Kind
B2
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).

Claims (15)

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.

Assignments (3)
CHANGE OF NAME Recorded Aug 18, 2026
From: SAGE THERAPEUTICS, INC.
To: SAGE THERAPEUTICS, LLC
Reel/Frame 075866/0450 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 16, 2023
From: KANES, STEPHEN JAY
To: SAGE THERAPEUTICS, INC.
Reel/Frame 064607/0856 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 6, 2021
From: COLQUHOUN, HELEN
To: SAGE THERAPEUTICS, INC.
Reel/Frame 057104/0352 →
Continuity (7)
Continuation 16083339
Provisional Application 62360758 · Jul 11, 2016
Provisional Application 62305279 · Mar 8, 2016
Provisional Application 62360762 · Jul 11, 2016
Provisional Application 62355669 · Jun 28, 2016
Provisional Application 62355174 · Jun 27, 2016
Related Publication 20200171049A1 · Jun 4, 2020
Cited By (9)
US 12,186,327 US 12,201,640 US 12,208,103 US 12,358,942 US 12,409,185 US 12,473,327 US 12,527,805 US 12,534,495 US 12,655,175