Abstract:
This disclosure relates to a solid pharmaceutical formulation comprising an amorphous neurosteroid dispersed in a polymer matrix that is suitable for oral administration. The disclosure also relates to methods for effectively treating an epileptic disorder, central nervous system disorder, or a neurological disorder. The methods disclosed herein comprise orally administering to a subject in need thereof a therapeutically effective amount of the solid pharmaceutical formulation disclosed herein comprising an amorphous neurosteroid, preferably ganaxolone dispersed in a polymer matrix.
Abstract:
This invention relates to methods for treating super refractory status epilepticus by rapidly weaning the subject in need thereof off an anesthetic agent prior to initiation of administering to the subject in need thereof of ganaxolone at a high infusion dose. The method provides SE suppression and continued suppression of SE.
Abstract:
This invention relates to methods for treating status epilepticus by administering to the subject in need thereof an intravenous bolus of ganaxolone and a continuous intravenous infusion of a neurosteroid. The method provides SE suppression and continued suppression of SE.
Abstract:
The disclosure to methods for treating tuberous sclerosis complex or tuberous sclerosis complex-related epilepsy, comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutically acceptable pregnenolone neurosteroid, such as ganaxolone, to reduce one or more symptoms of tuberous sclerosis complex or tuberous sclerosis complex-related epilepsy.
Abstract:
In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Abstract:
Uses of ganaxolone in prophylaxis and treatment of postpartum depression are described. A dose of ganaxolone is administered to a female suffering from postpartum depression or at risk of developing postpartum depression in an amount and at a rate sufficient to alleviate at least one symptom of postpartum depression in the female.
Abstract:
In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Abstract:
In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Abstract:
In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Abstract:
Applicants have discovered a method for the stereoselective and regioselective synthesis of 3α-hydroxy, 3β-methyl-5α-pregnan-20-one (ganaxolone) comprising reacting 5α-pregnane-3,20-dione; with an organometallic methylating agent in an inert solvent to provide a compound of the formula