Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1998-12-16
2000-03-28
Jarvis, William R. A.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
A61K 3144
Patent
active
060432586
DESCRIPTION:
BRIEF SUMMARY
This invention provides a method for using 3-(4-hexyloxy-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine, (hereinafter referred as "xanomeline"), for the treatment of disruptive behavior disorders.
A subject suffering from a Disruptive Behavior Disorder exhibits a consistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. Such subjects must suffer clear evidence of interference with developmentally appropriate social, academic, or occupational functioning. Individuals suffering from a Disruptive Behavior Disorder may fail to give close attention to details or may make careless mistakes in schoolwork or other tasks. Individuals often have difficulty sustaining attention in tasks or play activities and find it difficult to persist with tasks to completion. Tasks that require sustained mental effort are experienced as unpleasant and markedly aversive. As a result, these individuals typically avoid or have a strong dislike for activities that demand sustained self-application and mental effort or that require organizational demands or close concentration (e.g., homework or paperwork). Individuals suffering from a Disruptive Behavior Disorder have difficulty in common situations that require sustained attention, for example listening to a classroom teacher, doing class assignments, listening to or reading lengthy materials, or working on repetetive tasks. The condition manifests itself in adolescents and adults as a feeling of restlessness and difficulty engaging in quiet sedentary activities. If untreated, the condition may result in compromised school adjustment and feelings of jitteriness.
Disruptive Behavior Disorders are prevalent conditions afflicting elementary school-age children as well as adolescents and adults. It is estimated that from 3-5% of elementary school-age children suffer from Attention Deficit/Hyperactivity Disorder.
Applicants have discovered that xanomeline, thought to be a muscarinic agonist, can be useful for treating such Disruptive Behavior Disorders. More specifically, the invention provides a method of treating Attention Deficit/Hyperactivity Disorder in a mammal using xanomeline. Further, the present invention provides a method of treating Attention Deficit/Hyperactivity Disorder in a human using xanomeline.
As noted hereinbefore, the compound employed in the method of the present invention is known. Methods of preparing the compound, as well as pharmaceutical formulations containing the compound, are taught by Sauerberg in U.S. Pat. No. 5,043,345 (hereinafter referred to as the "'345 patent") herein incorporated by reference. The '345 patent teaches that xanomeline can be useful for treating Alzheimer's Disease and as stimulants of the cognitive function of the forebrain and hippocampus of mammals. Unlike Alzheimer's Disease, the onset of Attention Deficit/Hyperactivity Disorder is before the age of seven and has many different etiologies. Xanomeline may address a long felt need for new treatments which provide a favorable safety profile and effectively provides relief for the patient or individual suffering from a Disruptive Behavior Disorder.
The presently claimed invention provides a method for treating a Disruptive Behavior Disorder, comprising administering an effective amount of a compound of Formula I: ##STR1## or a pharmaceutically acceptable salt or solvate thereof to a patient in need of such treatment.
The presently claimed invention provides a method for treating Attention Deficit/Hyperactivity Disorder, comprising administering an effective amount of a compound of Formula I: ##STR2## or a pharmaceutically acceptable salt or solvate thereof to a patient in need of such treatment.
As used herein, the term "Disruptive Behavior Disorder" shall refer to a condition characterized as a Disruptive Behavior Disorder, in the DSM-IV-R. Diagnostic and Statistical Manual of Mental Disorders, Revised, 4th Ed (1994) as catagories 314.xx, 312.xx, and 31
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Katzung, B.G., Basic & Clinical Pharmacology, (Appleton & Lange, Norwald), 90-94 (1995).
Sauerberg, et al., J. Med. Chem., 35, 2274-2283 (1992).
Bymaster Franklin P
Shannon Harlan E
Eli Lilly and Company
Jarvis William R. A.
Stemerick David M.
Vorndran-Jones MaCharri R.
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