Compositions for reduction of side effects

Abstract

The present invention provides drug therapy formulations. In some embodiments, the present invention provides combinations of pharmaceutical agents (e.g., stimulant and non-stimulant), pharmaceutical formulations (e.g., nanoparticualte, non-nanoparticualte, etc.), and release profiles (e.g., immediate release, delayed release, sustained release, etc.) to provide therapeutic benefit with reduced side effects.

1 - 88 . (canceled) 
     
     
         89 . A method of treating a subject with ADHD, the method comprising:
 administering to the subject a once daily dose of a pharmaceutical composition comprising:   a) nanoparticulate formulated stimulant for rapid release and rapid onset of therapeutic action; and   b) a non-stimulant;   wherein the pharmaceutical composition is formulated for sequential release of the stimulant followed by the non-stimulant.   
     
     
         90 . The method of  claim 89 , wherein said stimulant is an amphetamine. 
     
     
         91 . The method of  claim 89 , wherein said stimulant is a methylphenidate. 
     
     
         92 . The method of  claim 89 , wherein said stimulant or non-stimulant is provided as a prodrug. 
     
     
         93 . The method of  claim 92 , wherein said stimulant is lisdexamfetamine. 
     
     
         94 . The method of  claim 89 , wherein said non-stimulant is guanfacine. 
     
     
         95 . The method of  claim 89 , wherein the pharmaceutical composition is formulated for sequential release of the stimulant between 0.15 hours or less and 2 hours and non-stimulant between 3 and 12 hours. 
     
     
         96 . The method of  claim 89 , wherein the non-stimulant is coated for enteric release. 
     
     
         97 . The method of  claim 89 , wherein the pharmaceutical composition comprises 10 mg or less of said stimulant. 
     
     
         98 . The method of  claim 89 , wherein said pharmaceutical composition is formulated to provide a peak blood concentration of said stimulant in less than 15 minutes after administration. 
     
     
         99 . The method of  claim 89 , wherein said pharmaceutical composition further comprises an agent to deter abuse of said pharmaceutical composition. 
     
     
         100 . The method of  claim 89 , wherein the subject is a human child under the age of 18. 
     
     
         101 . The method of  claim 89 , wherein the subject is a human adult. 
     
     
         102 . The method of  claim 89 , wherein said administration produces three release peaks in the plasma of said subject. 
     
     
         103 . The method of  claim 102 , wherein said three release peaks are two stimulant peaks and one non-stimulant peak. 
     
     
         104 . The method of  claim 90 , wherein said nanoparticulate formulated amphetamine is prepared by a method comprising milling said amphetamine in ethanol to produce a dry powder nanoparticulate amphetamine. 
     
     
         105 . A pharmaceutical composition comprising:
 a) nanoparticulate formulated amphetamine formulated for rapid release and rapid onset of therapeutic action; and   b) guanfacine formulated for sequential release after said amphetamine.   
     
     
         106 . The composition of  claim 105 , wherein said guanfacine is coated for enteric release. 
     
     
         107 . The composition of  claim 105 , wherein the pharmaceutical composition is formulated for sequential release of the amphetamine between 0.15 hours or less and 2 hours and guanfacine between 3 and 12 hours. 
     
     
         108 . The composition of  claim 105 , wherein the pharmaceutical composition comprises 10 mg or less of said amphetamine.