Dosing Regimens for Fast Onset of Antidepressant Effect

Abstract

A dose regimes comprising the simultaneous administration of two pharmaceutical compositions, wherein the first pharmaceutical composition is a composition comprising vortioxetine or a pharmaceutically acceptable salt thereof for once daily oral administration, and the second pharmaceutical composition is a composition comprising vortioxetine or a pharmaceutically acceptable salt thereof which together with said first composition quickly achieves a steady-state plasma level of vortioxetine in said patient which steady-state plasma level is the same as the steady-state vortioxetine plasma level achieved by the administration to said patient of said first composition alone.

1 . A method for the treatment of depression, said method comprising:
 simultaneously administering two pharmaceutical compositions to a patient in need thereof,   wherein the first pharmaceutical composition is a composition comprising vortioxetine or a pharmaceutically acceptable salt thereof for once daily oral administration, and the second pharmaceutical composition is a composition comprising vortioxetine or a pharmaceutically acceptable salt thereof which, together with said first composition, achieves a steady-state plasma level of vortioxetine in said patient within 36 hours from said simultaneous administration, which steady-state plasma level is essentially the same as the steady-state vortioxetine plasma level achieved by the administration to said patient of said first composition alone; and   wherein said second pharmaceutical composition is administered nasally.   
     
     
         2 . The method of  claim 1 , wherein said first pharmaceutical composition comprises 5 mg-20 mg vortioxetine or a pharmaceutically acceptable salt thereof, and the second pharmaceutical composition is a composition comprising vortioxetine or a pharmaceutically acceptable salt thereof which, together with said first composition, achieves a steady-state plasma level between 68 ng h/ml and 1625 ng h/ml vortioxetine in said patient within 24 hours from said simultaneous administration. 
     
     
         3 . The method of  claim 1 , wherein said first pharmaceutical composition comprises 5 mg-20 mg vortioxetine or a pharmaceutically acceptable salt thereof and said second pharmaceutical composition comprises 7 mg-57 mg vortioxetine or a pharmaceutically acceptable salt thereof for nasal administration to achieve a steady-state plasma level of vortioxetine between 68 ng h/ml and 1625 ng h/ml vortioxetine in said patient within 24 hours from said simultaneous administration. 
     
     
         4 . The method of  claim 1 , comprising simultaneously administering 10 mg vortioxetine or a pharmaceutically acceptable salt thereof once daily through oral administration and a single dose of 14 mg-29 mg vortioxetine nasally administered with the oral administration. 
     
     
         5 . The method of  claim 1 , wherein the first pharmaceutical composition is in the form of a capsules, a tablet, a dragee, a pill, a lozenge, a powder, or granules. 
     
     
         6 . A kit, comprising:
 an oral pharmaceutical composition comprising 5 mg-20 mg vortioxetine or a pharmaceutical acceptable salt thereof for once daily oral administration; and   a second pharmaceutical composition for nasal administration comprising 7 mg-57 mg vortioxetine or a pharmaceutically acceptable salt thereof.   
     
     
         7 . The kit of  claim 6 , wherein the oral pharmaceutical composition comprises 10 mg vortioxetine or a pharmaceutical acceptable salt thereof. 
     
     
         8 . The kit of  claim 6 , wherein the oral pharmaceutical composition is in the form of a capsules, a tablet, a dragee, a pill, a lozenge, a powder, or granules. 
     
     
         9 . The kit of  claim 6 , wherein the second pharmaceutical composition comprises 14-29 mg vortioxetine or a pharmaceutically acceptable salt thereof.