Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-01-08
2001-05-01
Jordan, Kimberly (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
Reexamination Certificate
active
06225283
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a therapeutic agent for the treatment of a psychotic symptom accompanying anorexia nervosa. More particularly, the present invention relates to a therapeutic agent for the treatment of an abnormal eating behavior in anorexia nervosa attributable to an abnormally increased central GRH level.
PRIOR ART
Anorexia nervosa (or nervous asitia, apocleisis) is a disease exhibiting psychotic symptoms such as a characteristic desire for emaciation and an abnormal eating behavior as well as somatic symptoms such as an extreme leptosome observed as a weight loss by 20% or more of the standard body weight as well as amenorrhea, and develops frequently in juvenile women. It is diagnosed generally based on the following clinical findings.
A: Abnormal weight loss by 20% or more of standard body weight
B: Abnormal eating behavior (apocleisis, vomiting, eating in secret, hyperphagia and the like)
C: Obsessed recognition with regard to body weight or body shape
D: Onset age of 30 years old or younger
E: Amenorrhea (in women)
F: Absence of organic disease causative of emaciation (such as schizophrenia and depression)
It is a serious, sometimes fatal disease with no insight in a patient.
In a current treatment, a less potent psychotropic agent or an antianxiety agent is administered depending on the symptoms and an oral tube feeding diet or a high calorie drip infusion is employed for recovery from an extreme physical exhaustion (See, “Today's treatment guideline”, IGAKUSHOIN (1995 Ed.), p248). However, no essential therapeutic agents capable of removing the psychotic symptoms characteristic of anorexia nervosa and also capable of normalizing the eating behavior have been reported.
On the other hand, human growth hormone (hereinafter abbreviated as hGH) is employed in the treatment of pituitary dwarfism and is believed to be effective also in the promotion of the healing of fractures and burn wounds and in the treatment of a patient having a reduced absorption of nutrition (“NIKKEI BIONENKAN” 94/95). Nevertheless, except for the improvement and exaltation in feeling associated with the recovery from a physical exhaustion state, no effectiveness of hGH against the typical psychotic symptoms has not been suggested.
Recently, a patent disclosed that administration of hGH is useful against various diseases caused by the reduction in triiodothyronine (T3) which is a thyroid hormone (WO95/24919). The inventors mentioned anorexia nervosa as an example of disease of T3 reduction syndrome, but all clinical effects of hGH they observed were an hGH-induced improvement in insufficient nutrition absorption only in the peripheral tissues after a trauma or an organ implantation, and all of their data (increased blood IGF-I level and reduced urinary nitrogen) can be interpreted based on the known peripheral effects of hGH.
SUMMARY OF THE INVENTION
An objective of the present invention is to provide a therapeutic agent for the treatment of the psychotic symptoms of anorexia nervosa which may be a core of this disease. As a result, a patient having anorexia nervosa which is difficult to treat and which imposes a substantial load on the family and the physicians can satisfactorily be treated.
We focused on the findings that in anorexia nervosa the level of IGF-I (insulin-like growth factor-I) is low in spite of the exhaustion state exhibiting an increased blood hGH level, and then the extensive studies resulted in an understanding that in this disease the central GRH level is elevated and it triggers the psychotic symptoms. Then we administered hGH to a typical anorexia nervosa patient, and observed a psychotic symptom improving effect in addition to a peripheral nutriture recovering effect, whereby establishing the present invention. These effects may be due to the negative feedback to the central GRH secretion by an exogeneous hGH.
Thus, the present invention relates to the following pharmaceuticals:
(1) A therapeutic agent for the treatment of a psychotic symptom accompanying anorexia nervosa comprising a human growth hormone as an active ingredient.
(2) A therapeutic agent according to item (1) wherein said psychotic symptom accompanying anorexia nervosa is abnormal eating behavior.
(3) A therapeutic agent according to item 1 or 2 wherein the anorexia nervosa is accompanied by abnormality in biochemical parameters of A or B given below:
A: Increased level of central growth hormone releasing factor (GRH)
B: Reduced blood IGF-I response to increased growth hormone (hGH)
REFERENCES:
patent: 8-165250A (1996-06-01), None
CA 123:330385, Petersen et al., 1995.*
Eur. J. Endocrinol. vol. 136. 136, No. 5 (1997) pp. 445-460.
Clinical Endocrinology, vol. 25, No. 6 (1977) pp. 657-660 (Chemical Abstracts, vol. 87 (1977) Abstract No 82675).
Horm, Metab. Res., vol. 24, No. 6 (1992) pp. 297-299.
Birch & Stewart Kolasch & Birch, LLP
Jordan Kimberly
Sumitomo Pharmaceuticals Company Limited
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