Oral Allopregnanolone Compositions and Methods of Use

An oral pharmaceutical composition for use in treating depression, said composition comprising at least about 3% w/w of allopregnanolone, a hydrophilic additive, and a lipophilic additive,

• wherein said hydrophilic additive comprises a hydrophilic surfactant having an HLB value of at least about 10, and wherein said lipophilic additive comprises a lipophilic surfactant having an HLB value of less than about 10, and
• wherein administration of said composition to a subject having depression results in said subject at least one of prevention of an increase of said depression and reduction of said depression, and
• wherein administration of said composition to said subject results in said subject at least one of:
• a dose normalized minimum AUC0-24 of at least one of about 0.60 h/L, about 0.65 h/L, about 0.70 h/L, about 0.75 h/L, about 0.80 h/L, about 0.85 h/L, about 0.90 h/L, about 0.95 h/L, about 1.00 h/L, about 1.10 h/L, and about 1.20 h/L, and
• a minimum AUC0-24 of at least one of about 18 ng*h/mL, about 19 ng*h/mL, and about 20 ng*h/mL.

A method of treating depression comprising administering to a subject having depression an oral pharmaceutical composition comprising at least about 3% w/w of allopregnanolone, at least about 7% w/w of a hydrophilic additive, and at least about 0.9% w/w of a lipophilic additive,

• wherein administration of said composition to said subject results in said subject at least one of prevention of an increase of said depression and reduction of said depression, and
• wherein administration of said composition to said subject results in said subject at least one of:
• a dose normalized minimum AUC0-24 of at least one of about 0.60 h/L, about 0.65 h/L, about 0.70 h/L, about 0.75 h/L, about 0.80 h/L, about 0.85 h/L, about 0.90 h/L, about 0.95 h/L, about 1.00 h/L, about 1.10 h/L, and about 1.20 h/L, and
• a minimum AUC0-24 of at least one of about 18 ng*h/mL, about 19 ng*h/mL, and about 20 ng*h/mL.

A method of treating depression comprising administering to a subject having depression an oral pharmaceutical composition comprising at least about 3% w/w of allopregnanolone, a hydrophilic additive, and a lipophilic additive,

• wherein said hydrophilic additive comprises a hydrophilic surfactant having an HLB value of at least about 10, and wherein said lipophilic additive comprises a lipophilic surfactant having an HLB value of less than about 10, and
• wherein administration of said composition to a subject having depression results in said subject at least one of prevention of an increase of said depression and reduction of said depression, and
• wherein administration of said composition to said subject results in said subject at least one of:
• a dose normalized minimum AUC0-24 of at least one of about 0.60 h/L, about 0.65 h/L, about 0.70 h/L, about 0.75 h/L, about 0.80 h/L, about 0.85 h/L, about 0.90 h/L, about 0.95 h/L, about 1.00 h/L, about 1.10 h/L, and about 1.20 h/L, and
• a minimum AUC0-24 of at least one of about 18 ng*h/mL, about 19 ng*h/mL, and about 20 ng*h/mL.