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 β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., CAPTISOL®; and methods of use in treating CNS disorders.

1 - 42 . (canceled) 
     
     
         43 . A method of treating a CNS-related disorder in a subject in need thereof, comprising administering to the subject an effective amount of an aqueous pharmaceutical composition formulated for parenteral administration comprising allopregnanolone at a concentration of 5 mg/mL, sulfo butyl ether β-cyclodextrin at a concentration of about 250 mg/mL, and a citrate buffer, wherein the pH of the composition is from 5 to 9, and wherein the CNS-related disorder comprises seizure or status epilepticus. 
     
     
         44 . The method of  claim 43 , wherein the composition is formulated for intravenous administration. 
     
     
         45 . The method of  claim 43 , wherein the composition further comprises an antioxidant. 
     
     
         46 . The method of  claim 43 , wherein the composition has a pH of about 6. 
     
     
         47 . The method of  claim 43 , wherein the composition is formulated for subcutaneous administration. 
     
     
         48 . The method of  claim 43 , wherein the composition is contained within a glass vial. 
     
     
         49 . The method of  claim 43 , wherein the CNS-related disorder is seizure. 
     
     
         50 . The method of  claim 43 , wherein the CNS-related disorder is status epilepticus. 
     
     
         51 . The method of  claim 50 , wherein the status epilepticus is refractory status epilepticus. 
     
     
         52 . The method of  claim 50 , wherein the status epilepticus is non-convulsive status epilepticus.