Anticonvulsant activity of steroids

Abstract

The present invention relates to methods of preventing, inhibiting, delaying, and/or mitigating seizures by administration of a steroid, e.g., a neurosteroid, e.g., allopregnanolone.

1 . A method of treating, reducing, and/or mitigating symptoms associated with and/or caused by traumatic brain injury, Alzheimer's disease, epilepsy, anxiety, fragile X syndrome, post-traumatic stress disorder, lysosomal storage disorders (Niemann-Pick type C disease), depression (including post-partum depression), premenstrual dysphoric disorder, alcohol craving, and smoking cessation in a subject in need thereof, comprising administration to the subject a composition comprising allopregnanolone and sulfobutylether-beta-cyclodextrin. 
     
     
         2 - 21 . (canceled) 
     
     
         22 . A composition comprising or consisting essentially of allopregnanolone and sulfobutylether-beta-cyclodextrin. 
     
     
         23 - 26 . (canceled) 
     
     
         27 . The composition  claim 22 , wherein the composition is formulated for intramuscular (i.m.), subcutaneous (s.c.) or intravenous (i.v.) administration. 
     
     
         28 . (canceled) 
     
     
         29 . The composition of  claim 22 , wherein the composition further comprises a buffer. 
     
     
         30 . The composition of  claim 29 , wherein the composition is a solution buffered to a pH in the range of about 4 to 8. 
     
     
         31 . The composition of  claim 30 , wherein the composition is a solution buffered to a pH in the range of about 5 to 7. 
     
     
         32 . The composition of  claim 29 , wherein the composition is buffered with phosphate buffered saline. 
     
     
         33 . The composition of  claim 22 , wherein the composition is prepared as a concentrated aqueous solution. 
     
     
         34 . The composition of  claim 22 , wherein the composition is formulated in a unit dosage form, each dosage containing from about 1-1000 mg allopregnanolone. 
     
     
         35 . The composition of  claim 22 , wherein the composition comprises allopregnanolone in 6% or 24% sulfobutylether-β-cyclodextrin. 
     
     
         36 . The composition of  claim 22 , wherein the composition comprises 1.5 mg/ml allopregnanolone in 6% sulfobutylether-β-cyclodextrin. 
     
     
         37 . A multiple or single dose container comprising the composition of  claim 22 .