Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2000-03-17
2002-05-28
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S273000, C514S220000, C514S258100
Reexamination Certificate
active
06395727
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a method of treating non-psychotic disorders by administration of antipsychotic medications. More specifically, the present invention relates to a method of treating the eating disorder Bulimia Nervosa, and bulimia-related eating disorders, by administration of antipsychotic medications from the group of compounds designated as “atypical” antipsychotic medications. In particular, this invention contemplates use of the atypical antipsychotic medication risperidone for treatment of Bulimia Nervosa and bulimia-related disorders.
BACKGROUND OF THE INVENTION
I. Bulimia Nervosa and Related Eating Disorders
Bulimia Nervosa (“ox like hunger of nervous origin”) was identified as a mental disorder in the early 1970's, but was considered to be an “ominous” variation of the then more recognized eating disorder, anorexia nervosa. Subsequent developments in the study of eating disorders has indicated that, although many anorexia nervosa patients are, or may become bulimic, Bulimia Nervosa is a separate disorder with a distinct set of clinically-defined symptoms and behaviors. The disorder anorexia nervosa can be generally characterized by an individual's refusal to maintain a minimally normal body weight usually effectuated through severe restriction of caloric intake. In contrast, Bulimia Nervosa and bulimia-related eating disorders are generally characterized by repeated episodes of binge eating, followed by inappropriate and unhealthy compensatory behaviors such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting or excessive exercise.
Bulimia Nervosa is of unknown etiology, but it affects a relatively large portion of the population. The Diagnostic and Statistical Manual of Eating Disorders, 4
th
ed., (DSM-IV), reports the prevalence of Bulimia Nervosa to be 1% to 3% within the adolescent and young adult female population, and one-tenth of that in the male population. No reliable statistics are available regarding the prevalence of bulimia-type eating disorders in these populations, but it is believed that the rate is similar, or greater, than that of Bulimia Nervosa. Bulimia Nervosa has been reported to occur with roughly similar frequencies in most industrialized countries, including the United States, Canada, Europe, Australia, Japan, New Zealand and South Africa. Thus, within the female population of industrialized nations, Bulimia Nervosa is at least as common as other major psychiatric disorders such as schizophrenia, which occurs at a rate of 1.5%, and Major Depressive Disorder, which occurs at a rate of 1.3%.
The essential features of Bulimia Nervosa are a disturbance in perception and a high level of preoccupation with body shape and weight, coupled with binge eating and inappropriate compensatory methods to prevent weight gain. Other characteristic behaviors, as well as the physical and psychological symptoms which give rise to a diagnosis of Bulimia Nervosa, are well-known in the art and are detailed in the DSM-IV at pages 545 to 550, the contents of which are incorporated herein by reference.
The diagnostic criteria for Bulimia Nervosa are highly defined; for a diagnosis of Bulimia Nervosa, individuals must exhibit particular behaviors and psychological symptoms with specified frequency. Frequently individuals engaging in disordered eating practices do not meet these DSM-IV criteria, but exhibit behaviors and thought patterns common to individuals diagnosed with Bulimia Nervosa, including binge eating, followed by compensatory behaviors and an undue preoccupations with body shape. These individuals are defined by the DSM-IV as having a Bulimia-Type Eating Disorder Not Otherwise Specified (Eating Disorder N.O.S.). The specific clinical criteria defining Bulimia-Type Eating Disorders N.O.S. are well-known in the art and are detailed in the DSM-IV at page 550, the contents of which are incorporated herein by reference.
The average age for the onset of Bulimia Nervosa or Bulimia-Type Eating Disorder N.O.S. is late adolescence or early childhood. The overwhelming majority of those who are afflicted, approximately 98%, are young women. In a high percentage of cases, the disturbed eating behavior persists for several years. Recovery rates for Bulimia Nervosa have been reported at 38% to 46%. The long-term outcome of Bulimia Nervosa is not known, but anecdotal evidence suggests that relapse is common.
Early epidemiological and family studies of eating disordered individuals demonstrated an apparent linkage between such disorders and mood disturbances. This initial observation has been reinforced further by clinical and physiological data. For example, studies of individuals diagnosed with Bulimia Nervosa have indicated a high frequency of comorbid diagnoses of axis I psychiatric disorders, including Major Depressive Disorder, and Bulimia Nervosa or Bulimia-Type Eating Disorder N.O.S. Further, research into the pathophysiological bases of eating disorders has implicated a disturbance in the serotonigenic system of eating disordered individuals, a neurotransmitter system also believed to play a role in mood disorders. Because of the several associations of Bulimia Nervosa and Bulimia-Type Eating Disorder N.O.S. with mood and anxiety disorders, most of the treatment modalities devised for Bulimia Nervosa and Bulimia-Type Eating Disorder N.O.S. have been developed from, or have been related to, treatment approaches developed for these disorders. In fact, a brief survey of the scientific literature reveals that, although they are not clinically defined as mood or anxiety disorders, Bulimia Nervosa and Bulimia-Type Eating Disorders N.O.S. are frequently treated with antidepressant medications, such as fluoxetine, imipramine and trazodone.
II. Atypical Antipsychotic Medications
Beginning in the early 1950's, a group of neuroleptic compounds were found to be effective for the treatment of schizophrenia and other psychotic disorders. These “typical” antipsychotic compounds function as antidopaminergic agents, primarily blocking the dopamine 2 (D2) receptors of the central nervous system, and are widely prescribed for the treatment of psychotic disorders. When used in the treatment of psychotic disorders, the compounds function to very effectively reduce “positive symptoms” of schizophrenia and related psychotic disorders, including delusions and hallucinations.
Typical antipsychotic compounds are well-known in the art and include drugs derived from phenothiazines, such as thioridazine and perphenazine; butyrophenone-derived compounds, such as haloperidol (Haldol); and compounds of the diphenylbutylpiperdine group, such as pimozide. The precise chemical compositions and configurations of these compounds can be found in the Merck Index, 12
th
ed., 1996, and are incorporated herein by reference. The compounds are dopamine antagonists, binding to dopamine (D2) receptors, thereby blocking the receptors and reducing or preventing receptor-dopamine binding.
The side effects caused by the typical antipsychotics are considerable, and can be life-threatening. Patients may suffer from akathisia, dystonias, muscle rigidity and shuffling gait, some of which is irreversible. Significant weight gain is a side effect also associated with the use of typical antipsychotics. The frequent occurrence of uncomfortable or unmanageable side effects often results in reduced compliance with, or increased cost of, the drug treatment regime.
Recently new compounds for use in the treatment of psychotic disorders have been developed. These compounds, designated “atypical” antipsychotics, to distinguish them from the “typical” or older antipsychotic medications, are primarily benzisoxals, and are characterized by their antagonistic action on multiple receptors, including the serotonin (5HT2) receptors and the dopamine (D2) receptors of the central nervous system. Some of the compounds, including risperidone, also act as blockers of the central andrengenic receptors. The current list of atypical antipsychotic drugs is wel
Guadagno Gina
Star Jodi M.
Criares Theodore J.
Goldstein Steven J.
The Cincinnati Children's Hospital Research Foundation
White Loy M.
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