Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1999-07-15
2001-06-12
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
Reexamination Certificate
active
06245812
ABSTRACT:
FIELD OF THE INVENTION
This invention is directed to a method for treating hot flashes (flushing) and the like. Specifically, this invention is directed to treatment of flushing and the like caused by means other than the normal reduction of estrogen associated with menopause comprising administering to a patient, an effective amount of leucine. Leucine may be administered by manipulation of diet or in a composition comprising an effective amount of leucine and a pharmaceutically acceptable carrier. A combination of leucine with other branched chain amino acids such as, isoleucine and valine is preferred.
BACKGROUND OF THE INVENTION
Menopausal syndrome consists of a number of varying and often highly distressing symptoms resulting from hormonal imbalance in the female body, specifically a deficiency of estrogen in the body. Symptoms of menopausal syndrome sufficiently severe to require treatment occur in approximately 50 percent of women. One particular symptom experienced by women is hot flashes or flushing. This is characterized by a sudden onset of warmth in the face and neck and often progressing to the chest. Such an episode generally lasts several minutes and is evidenced by a visible red flushing of the skin. Often such episodes are accompanied by sweating, dizziness, nausea, palpitations and diaphoresis.
In U.S. Pat. No. 5,789,443, granted on Aug. 4, 1998, the contents of which are expressly incorporated by reference as if fully set forth herein, the use of leucine either alone or in combination with other branched chain amino acids has been described for the treatment of flushing and the like associated with menopause.
Flushing, however, can be caused by other means than the reduction of estrogen resulting from the onset of natural or normal menopause. “Other means” refers to any causes of human flushing brought on by other than “normal” physical decreases in estrogen associated with normal or natural menopause. In other words, induced menopause can cause flushing. For example, flushing may be induced by certain drug administration. Drugs used to treat breast cancer, such as the anti-estrogens are known to induce flushing. Examples of the anti-estrogens include, but are not limited to, tamoxifen (1-p-&bgr;-dimethylamino-ethoxypenyl-trans-1,2-dipheriyl-but-1-ene), and droloxifene ((E)-alpha-(para-(2-(Dimethylamino)ethoxy) phenyl)-alpha′-ethyl-3-s-tilbenol), faslodex (7&agr;-(9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]estra-1,3,5(10)-triene-3-173-diol), and progestins such as, megestrol (17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione) and medroxyprogesterone ((6alpha)-17-Hydroxy-6-methylpregn-4-ene-3,20-dione). Another class of drugs used in the treatment of breast cancer is the aromatase inhibitors. Examples of the aromatase inhibitors include, but are not limited to, anastrazole (2,2[5-(1H-1,2,4-triazol-1-yl methyl)-1,3-phenylene]bis(2-methylpropiononitrile), fadrozole (4-(5,6,7,8-Tetrahydroimidazo(1,5-a)pyridin-5-yl)benzonitrile), letrozole (4-[1-(cyanophenyl)-1-(1,2,4-triazolyl)methyl]benzonitrile), vorzole (6-((4-chlorophenyl)-(1H-1,2,4-triazol-1-yl)methyl)-1-methyl-1H -benzotriazloe), aminoglutethimide(2-(p-aminophenyl)-2-ethyl -glutarimide), formestane (4-Hydroxyandrostenediona) and exermestane (6-Methyleneandrosta-1,4-diene-3,17-dione).
In the treatment of prostrate carcinoma, lutenizing hormone releasing hormone (LHRH) analogs are administered. Such endocrine therapy suppresses levels of testosterone and is known to cause flushing in about two thirds of the patients undergoing therapy. Examples of LHRH analogs include, but are not limited to, leuprolide acetate and goserelin acetate.
In the treatment of cancer, women subject to powerful drugs may cease menstruating and may experience flushing.
Flushing may be induced as a result of radiation therapy.
Flushing may also be induced by certain surgical procedures. Removal of the testes is known to induce flushing in about half the men receiving such a procedure. Removal of the ovaries is also known to induce flushing in women.
SUMMARY OF THE INVENTION
Flushing induced by other means than associated with menopause can also be successfully treated with leucine in accordance with the teachings of U.S. Pat. No. 5,789,443. Therefore, it is the object of the present invention to provide a method for treating flushing and the like, induced by means other than normal reductions in estrogen associated with normal or natural menopause.
In accordance with a first aspect, the present invention provides a method for the treatment of flushing and the like, by administering to a patient suffering from such symptoms, a therapeutically effective amount of leucine. The treatment of flushing and the like caused by means other than normal reductions in estrogen associated with menopause is envisioned. Preferably, leucine is administered to the patient orally, in combination with other branched chain amino acids such as isoleucine and valine.
In accordance with a second aspect, the present invention provides an article of manufacture which comprises at least one therapeutic composition comprising leucine, effective in the treatment of flushing and the like, and packaging material for containing the at least one therapeutic composition, the packaging material having a label which indicates that the at least one therapeutic composition is therapeutically effective in the treatment of flushing.
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Jacobson Price Holman & Stern PLLC
Travers Russell
Wang Shengjun
LandOfFree
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