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
2000-03-07
Henley, III, Raymond
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
060341084
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 autism and mental retardation.
Autism and mental retardation are seriously incapacitating conditions for which there has been little available treatment. The patient suffering from autism has gross and sustained impaired reciprocal social interaction. Impairment in communication is marked and sustained as well. The autistic patient suffers from restricted repetitive and stereotyped patterns of behavior, interests, and activies which are non-functional and/or abnormal in either intensity or focus. Further, the juvenile patient younger than three years old displays delays in at least one of the following areas: social interaction, language as used in social communication, or symbolic or imaginative play.
The patient suffering from mental retardation has subaverage general intellectual functioning. The onset of such subaverage intellectual functioning is before the age of 18 (eighteen) years.
Both mental retardation and autism can be debilitating conditions which may require institutionalization, if severe.
Applicants have discovered that 3-(4-hexyloxy-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine, thought to be a muscarinic agonist, can be useful for treating autism and/or mental retardation. More specifically, the invention provides a method of treating mental retardation in a mammal using 3-(4-hexyloxy-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine. Further, the present invention provides a method of treating autism in a human using 3-(4-hexyloxy-1,2,5-thiadiazol-3-yl)-1,2,5,6-tetrahydro-1-methylpyridine.
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 Suaerberg 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 a stimulant of the cognitive function of the forebrain and hippocampus of mammals. Unlike Alzheimer's Disease, the onset of mental retardation is before the age of eighteen and has many different etiologies. Further, a patient suffering from autistic disorder may have average or above average intelligence in one or more skills. The autistic patient suffers from a markedly abnormal or impaired development in social interaction and communication and a markedly restricted repertoire of activity and interests. Applicants have discovered that xanomeline can be useful for the treatment of both mental retardation and/or autism. Xanomeline may address the long felt need for treatments which provide a favorable safety profile and effectively provides relief for the patient or individual suffering from autism and/or mental retardation.
The presently claimed invention provides a method for treating autistic 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 mental retardation, 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 "autistic disorder" shall refer to a condition characterized as an Autistic Disorder, in the DSM-IV-R. Diagnostic and Statistical Manual of Mental Disorders, Revised, 4th Ed. (1994) as catagory 299.00. The DSM-IV-R was prepared by the Task Force on Nomenclature and Statistics of the American Psychiatric Association, and provides clear descriptions of diagnostic catagories. The skilled artisan will recognize that there are alternative nomenclatures, nosologies, and classification systems for pathologic phychological conditions and that t
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Bymaster Franklin P
Shannon Harlan E
Eli Lilly and Company
Henley III Raymond
Stemerick David M.
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