Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2000-05-05
2002-03-05
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S239200, C514S239500, C514S238800
Reexamination Certificate
active
06352986
ABSTRACT:
FIELD OF THE INVENTION
This invention describes new treatments for several nervous system disorders, including: Addictive Disorders, Psychoactive Substance Use Disorders, Nicotine Addiction or Tobacco Addiction resulting in Smoking Cessation and Attention Deficit Hyperactivity Disorder (ADHD). The treatment involves the administration of the drug Reboxetine to a patient in need.
BACKGROUND
The introduction of tricyclic antidepressants in the early 1960s has provided a major advance in the treatment of neuropsychiatric disorders. Reactive and endogenous depressions, diagnoses formerly carrying grave prognostic implications, have become, with the introduction of the tricyclics, manageable disorders with a much smaller toll on the patient and the society as a whole. Electroconvulsive Shock Therapy once the only efficacious treatment in spite of its highly invasive nature, has now become, thanks to tricyclics, an obsolete form of treatment in most Countries.
The early tricyclic compounds were reuptake inhibitors of all the catecholamines released in the synaptic cleft, thus resulting in prolongation and enhancement of the dopamine (DA), noradrenaline (NA) and serotonin (5-hydroxytryptamine=5-HT) action. Desipramine, for example, has been characterized as “one of the most studied of the tricyclic anti-depressants in ADHD children and adolescents.” T. E. Wilens, et al.
Am. J. Psychiatry
153:1147-1153, 1148 (1996). It has also been considered as a treatment for the disease in adults. Id. Unfortunately, a lack of selectivity for most tricyclics, including desipramine can also cause undesired side effects particularly on the acetylcholine (especially the muscarinic component), and histamine mediated neurotransmission.
Because of these unwanted pharmacodynamic activities, cognitive impairment, sedation, urinary and gastrointestinal tract disturbances, increased intraocular pressure were limiting factors in the clinical use of these compounds and often required discontinuation of treatment. Of utmost concern were also the cardiac toxic effects and the proconvulsant activity of this group of drugs.
Another drug, methylphenidate, is also known to have clinical efficacy for the treatment of ADHD. Wender, P. H., et al.
Am. J. Psychiatry
142:547-552 (1985).
More recently, selective reuptake inhibitors for serotonin (SSRI) have been introduced with definite advantages in regard to fewer side effects without loss of efficacy.
Here we present the surprising finding that one particular drug from a new category of antidepressants, a so called noradrenaline (NA) reuptake inhibitor can be used to manage or treat a few special diseases, diseases having symptoms outside of what are usually considered depression symptoms. Now these diseases may be treated with Reboxetine.
SUMMARY OF THE INVENTION
This patent application describes the treatment of Addictive Disorders, Psychoactive Substance Use Disorders, Nicotine Addition or Tobacco Addiction (with a result of Smoking Cessation or a decrease in smoking) and Attention Deficit Hyperactivity Disorder (ADHD), comprising administering a therapeutically effective, nontoxic dose of Reboxetine and derivatives and or pharmaceutically acceptable salts thereof to a patient.
Reboxetine is the generic name of the pharmaceutical substance with the chemical name of 2-(I-((2-ethoxyphenoxy)benzyl)-morpholine, and its pharmaceutically acceptable salts. Reboxetine can be a free base, or it can include reboxetine methanesulfonate (also called reboxetine mesylate) or any other pharmaceutically acceptable salt that does not significantly affect the pharmaceutical activity of the substance.
A preferred dose range is 4 to 10 mg per patient per day and the most preferred dose is 6 to 8 mg or 8 to 10 mg per patient daily, depending upon the patient, delivered twice a day (b.i.d.).
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Frances, R. J., and Franklin, J. E. Jr., “Alcohol and Other Psychoactive Substance Use Disorders,”The American Psychiatric Press Textbook of Psychiatry, Second Edition,edited by Robert E. Hales, Stuart C. Yudofsky, and John A. Talbott, copyright 1994, incorporated by reference, especially pp. 401 et. seq., section on “Nicotine” incorporated by reference.
Leonard, B. E.: “Noradrenaline in basic models of depression”, European Neuropsychopharmacology, vol. 7, no. suppl. 1, 1997, pp s111-s16.
Pleak, R.A. eta al: “Effects of venlafaxine treatment for ADHD in a child”, American Journal of Psychiatry, vol. 152, No. 7, Jul. 1995, p. 1099.
Popper, C. W., and Steingard, R. J., “Disorders Usually First Diagnosed in Infancy, Childhood, or Adolescence,”The American Psychiatric Press Textbook of Psychiatry, Second Edition, edited by Robert E. Hales, Stuart C. Yudofsky, and John A. Talbott, copyright 1994, incorporated by reference, epecially pp. 741 et. al., section on “ADHD,” incorporated by reference.
Shader, R. I., “Hypnosis,”Manual of Phyciatric Therapeutics, Second Edition, edited by Richard I. Shader, incorporated by reference, especially pp. 85 from Chapter 11(Hypnosis).
Svestka, J., “Antidepressives of the 3rd, 4th, and 5thgeneration,” CESK-Psychiatr. 1994 Feb;90(1):3-19. (Czech).
Wender, P.H., et. al., “A Controlled Study of Methylphenidate in the Treatment of attention Deficit Disorder, Residual Type, in Adults,”AM J. Psychiatry142:547-552 (1985).
Wender, P. H., and Shader, R. I.,Manual of Psychiatric Therapeutics, Second Edition, edited by Richard I. Shader, incorporated by reference, especially Chapter 18, Diagnosis and Treatment of Attention-Deficit Hyperactivity Disorder in Children and Adults, and pp. 172 et. seq., incorporated by reference.
Wilens, T.E., Spencer, T.J., Biederman, J., “Pharmacotherapy of attention deficit hyperactivity disorder”. Current Opinions in CPNS Investigational Drugs, 1:453-465 (1999).
Fong Wong Erik Ho
Hassan Fred
McCall John Michael
Taylor Duncan Paul
Von Voigtlander Philip F.
Fay Zohreh
Nesbitt Stephen L.
Pharmacia & Upjohn Company
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