Composition and method for treatment of neurophychiatric disorders

Abstract

The present invention relates to a composition and method for combinative therapy, capable of temporarily regulating inherent dysfunctional neural processes and reducing symptoms and/or signs of neuropsychiatric disorders including, but not limited to, psychostimulant use disorder (PUD) and other substance-related additive disorders, post-traumatic stress disorder (PTSD) and other trauma- and stress-related disorders, and levodopa-induced dyskinesia (LID) and other types of dyskinesias. The present specification shows specific examples of a dosage form.

1 .- 26 . (canceled) 
     
     
         27 . A method of treating a neuropsychiatric disorder comprising:
 a) administering a dosage form comprising methylphenidate or a pharmaceutically acceptable salt thereof and ondansetron or a pharmaceutically acceptable salt thereof;   b) having the methylphenidate or a pharmaceutically acceptable salt thereof exhibit a T max1  and the ondansetron or a pharmaceutically acceptable salt thereof exhibit a T max2 ; and wherein the T max2  is greater than T max1  and the difference between T max2  and T max1  is about 2 to about 7 hours.   
     
     
         28 . The method of  claim 27 , wherein
 the methylphenidate or pharmaceutically acceptable salt thereof dissolves greater than or equal to about 80% within about 1 hour or greater than or equal to about 90% within about 2 hours under simulated gastric or intestinal dissolution test conditions; and   the ondansetron or pharmaceutically acceptable salt thereof dissolves less than or equal to about 20% in greater than or equal to 3 hours and greater than or equal to about 80% within 6 hours under simulated gastric or intestinal dissolution test conditions.   
     
     
         29 . The method of  claim 27  wherein the methylphenidate has a terminal elimination half-life of less than or equal to 5 hours and the ondansetron has a terminal elimination half-life of about 3 hours to 13 hours. 
     
     
         30 . The method of  claim 27 , wherein the neuropsychiatric disorder further comprises one or more of a substance-related disorder, a behavioral addictive disorder, a psychostimulant use disorder or a trauma and stressor-related disorder. 
     
     
         31 . The method of  claim 30 , wherein the psychostimulant use disorder comprises misuse of one or more of cocaine or methamphetamine 
     
     
         32 . The method of  claim 30 , wherein the substance-related disorder comprises one or more of alcohol use disorder, cannabis use disorder, opioid use disorder or tobacco use disorder. 
     
     
         33 . The method of  claim 30 , wherein the behavioral addictive disorder comprises one or more of a gambling disorder, or an internet addiction disorder. 
     
     
         34 . The method of  claim 30 , wherein the trauma and stressor-related disorder comprises one or more of acute stress disorder or post-traumatic stress disorder. 
     
     
         35 . The method of  claim 27 , wherein the dosage form comprises about 5 mg to 80 mg of methylphenidate or a pharmaceutically acceptable salt thereof and about 4 mg to about 16 mg of ondansetron or a pharmaceutically acceptable salt thereof.