Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Patent
1998-12-29
2000-08-29
Barts, Samuel
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
A61K 3114
Patent
active
06110972&
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to methods for treating urinary incontinence, such as incontinence caused by bladder detrusor muscle instability, and to pharmaceutical compositions for such treatment.
BACKGROUND OF THE INVENTION
Urinary incontinence is a prevalent problem that affects people of all ages and levels of physical health, both in healthcare settings and in the community at large. At present, urinary incontinence afflicts 15-30% of elderly people living at home, one-third of those living in acute-care settings, and at least one-half of those in long-term care institutions (R. M. Resnick, Lancet 346:94 (1995)). Medically, it predisposes persons to urinary tract infections, pressure ulcers, perineal rashes, and urosepsis. Psychosocially, urinary incontinence is associated with embarrassment, social stigmatization, depression, and with the risk of institutionalization (Herzo et al., Annu. Rev. Gerontol. Geriatr., 9:74 (1989)). Economically, the costs are great; in the United States alone, over $10 billion is spent per annum managing incontinence.
Treatments for incontinence include drugs with bladder relaxant properties, i.e., which help to control bladder detrusor muscle overactivity. Such drugs are effective in 80 to 85% of patients with uninhibited bladder contractions, with anticholinergic medications representing the mainstay of this type of treatment. For example, anticholinergics such as propantheline bromide, and combination smooth muscle relaxant/anticholinergics such as racemic oxybutynin and dicyclomine, have been used to treat urge incontinence. (See, e.g., A. J. Wein, Urol. Clin. N. Am., 22:557-77 (1995).)
No treatment for incontinence, including existing drug therapies, has achieved complete success with all classes of incontinent patients, and without significant side effects. For example, adverse effects, such as drowsiness, dry mouth, constipation, blurred vision, headaches, and cardiac arrhythmia which are related to the anticholinergic activity of drugs such as racemic oxybutynin, occur frequently and can be sufficiently troublesome to necessitate discontinuing treatment in up to 25% of patients, depending on the dosage. Yet, despite the occurrence of unwanted anticholinergic effects in many patients, and an apparent lack of efficacy in the elderly institutionalized population, racemic oxybutynin nevertheless is considered the drug of first choice in patients with bladder detrusor muscle hyperactivity when pharmacological therapy is indicated (cf. Yarilur et al., Drugs Aging, 6:243 (1995)).
Another anticholinergic drug, tridihexethyl, (3-cyclohexyl-3-hydroxy-3-phenylpropyl)triethylammonim, has been described as an antiulcer medication, and like other anticholinergic drugs, the use of tridihexethyl results in a number of adverse effects arising from the anticholinergic activity of the drug, as previously described.
SUMMARY OF THE INVENTION
The present invention provides methods and compositions for treatment of urinary incontinence, including, e.g., bladder detrusor muscle instability incontinence, stress incontinence, urge incontinence, overflow incontinence, enuresis, and post-prostectomy incontinence, with (S)-tridihexethyl. The methods of the present invention provide for treatment of incontinence with fewer adverse effects than occur upon administration of racemic tridihexethyl.
One aspect of the present invention relates to methods for treating urinary incontinence by administration to a subject in need thereof a therapeutically effective amount of enantiomerically enriched (S)-tridihexethyl, or a pharmaceutically acceptable salt thereof. In a preferred embodiment of this method, the enantiomerically enriched (S)-tridihexethyl, or a pharmaceutically acceptable salt thereof, is substantially free of (R)-tridihexethyl.
The present invention also relates to methods for treating bladder detrusor muscle instability comprising administration to a subject in need thereof a therapeutically effective amount of enantiomerically enriched (S)-tridihexethyl, o
REFERENCES:
patent: 5492933 (1996-02-01), Gray et al.
Schill, et al., "Chiral Sepration of Cationic Drugs on an .alpha..sub.1 -Acid Glycoprotein Bonded Stationary Phase," Journal of Liquid Chromatography, 9:641-66 (1986) month unavailable.
Budavari, S. et al., "The Merck Index: An Encyclopedia of Chemicals, Drugs and Biologicals," Merck and Co., Inc. p. 1520 (1989) month unavailable.
Fabiano Vincent L.
McCullough John R.
Barts Samuel
Sepracor Inc.
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