Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1998-09-08
2000-11-21
Spivack, Phyllis G.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
A61K 31381
Patent
active
061503967
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
Interstitial cystitis is a chronic debilitating inflammatory disorder of the bladder. The disease is most common in women ranging in age from about thirty to sixty with onset of the condition typically occurring at about forty years of age. It is characterized by a number of urinary difficulties, such as suprapubic pressure and pain, with bladder filling, urinary frequency, nocturia, dysuria, urgency adn irritative voiding associated with morphological and histological changes in the bladder. The condition is characterized as "interstitial cystitis" because it is believed the condition does not affect the surface of the bladder, but instead involves the spaces between the cells, namely the interstices, in the lining of the bladder.
Urethral syndrome is a related painful voiding disorder of unknown etiology affecting women exhibiting many of the conditions set forth above.
As noted in U.S. Pat. No. 5,145,859, issued Sep. 8, 1992, the entire contents of which are herein incorporated by reference, there are a number of compounds proposed to treat these conditions, based on differing theories as to the etiology of interstitial cystitis and urethral syndrome. None of these treatment regimens has proven completely successful to date.
Because of the current dissatisfaction of the currently marketed treatments for interstitial cystitis within the affected population, there exists a need for a more efficacious and safe treatment.
SUMMARY OF THE INVENTION
This invention provides methods for the treatment or prevention of interstitial cystitis or urethral syndrome in a mammal which comprise administering to a mammal in need thereof an effective amount of duloxetine.
DETAILED DESCRIPTION AND PREFERRED EMBODIMENTS
Duloxetine is N-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine. It is usually administered as the (+) enantiomer, and as the hydrochloride salt. It was first taught by U.S. Pat. No. 4,956,388, which teaches the synthesis of the compound as well as its high potency as an uptake inhibitor of both serotonin and norepinephrine. The word "duloxetine" will be used here to refer to any acid addition salt or the free base of the molecule, as well as to either an enantiomer or the racemate. It is to be understood, however, that the (+) enantiomer is preferred.
The term "treating" (or "treat") as used herein includes its generally accepted meaning which encompasses prohibiting, preventing, restraining, and slowing, stopping, or reversing progression, severity, or a resultant symptom. As such, the methods of this invention encompass both therapeutic and prophylactic administration.
Duloxetine is a safe drug, and its use in treating or preventing interstitial cystitis or urethral syndrome, in both adults and children, is a superior treatment for that disorder because of its improved safety. The compound is particularly selective, having few if any physiological effects besides those on norepinephrine and serotonin processing, and therefore is free of side effects and unwanted activities. Further, it is effective at relatively low doses, as discussed below, and may safely and effectively be administered once per day. Thus, difficulties created by the multiple dosing of patients, who are children and disorganized adults, are completely avoided.
The most preferred dose of duloxetine for the treatment of a given patient with any particular disorder will vary, depending on the characteristics of the patient, as all clinicians and medical doctors are aware. Factors such as other diseases from which the patient suffers, the patient's age and size, and other medications which the patient may be using will have an effect on the duloxetine dose and will be taken into account. In general, however, the daily dose of duloxetine is from about 1 to about 80 mg. A more preferred dose range is from about 5 to about 40 mg, and another preferred range is from about 5 to about 20 mg, administered once daily.
Duloxetine is orally available and presently is orally administered, in the form of a tablet
REFERENCES:
patent: 5744474 (1998-04-01), Thor
Thor et al., J. Pharmacology & therapeutics, 274(2), 1014-24, Aug. 1995.
Iyengar Smriti
Muhlhauser Mark A.
Thor Karl B.
Anderson Arvie J.
Eli Lilly and Company
Gaylo Paul J.
Harvey Suzanne M.
Spivack Phyllis G.
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