Claims for Patent: 10,322,139

Summary for Patent: 10,322,139

Title:	Neuroactive steroid formulations and methods of treating CNS disorders
Abstract:	Formulations of comprising a neuroactive steroid, e.g., allopregnanolone; and optionally a cyclodextrin, e.g., a .beta.-cyclodextrin, e.g., a sulfo butyl ether .beta.-cyclodextrin, e.g., a .beta.-cyclodextrin, e.g., a sulfo butyl ether .beta.-cyclodextrin, e.g., CAPTISOL.RTM.; and methods of use in treating CNS disorders.
Inventor(s):	Reddy; Kiran (Boston, MA)
Assignee:	Sage Therapeutics, Inc. (Cambridge, MA)
Application Number:	15/649,583
Patent Claims:	1. An aqueous pharmaceutical composition formulated for parenteral administration comprising allopregnanolone at a concentration of about 5 mg/mL, sulfo butyl ether .beta.-cyclodextrin at a concentration of about 250 mg/mL, and a citrate buffer, wherein the pH of the composition is from 5 to 9. 2. The composition of claim 1, wherein the composition is formulated for intravenous administration. 3. The composition of claim 1, further comprising an antioxidant. 4. The composition of claim 1, wherein the pH of the composition is about 6. 5. The composition of claim 1, wherein the composition is formulated for subcutaneous administration. 6. The composition of claim 1, wherein the composition is contained within a glass vial.