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Therapy for the treatment of disease

a technology for treating diseases and diseases, applied in drug compositions, animal repellents, extracellular fluid disorders, etc., can solve the problems of lack of specificity, oab symptoms are generally underreported by patients, and healthcare professionals are not able to treat them effectively, so as to relieve constipation

Inactive Publication Date: 2009-11-05
THERAVIDA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The patent text describes pharmaceutical compositions that contain a combination of two compounds. The first compound is an antimuscarinic or anticholinergic agent, which can treat muscle spasms and excessive saliva production. The second compound causes stimulation of salivary glands. Additionally, the patent describes pharmaceutical compositions that also contain a third compound that can help with constipation. The technical effect of this patent is that it provides new ways to treat patients with these pharmaceutical compositions, which can provide more effective treatment for certain medical conditions."

Problems solved by technology

This condition affects more than 33 million Americans and imposes considerable economic, social, and psychological burdens.
Although continued research in the pharmacologic management of lower urinary tract disorders have led to alternative treatment options, the symptoms of OAB are generally underreported by patients and under-treated by healthcare professionals.
A major limitation of these agents is that they lack specificity for bladder tissue, with resultant bothersome side effects such as dry mouth and constipation.
Nonetheless, the dry mouth and constipation continue to be problematic and patients stop taking the medication after short period of therapy.

Method used

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  • Therapy for the treatment of disease
  • Therapy for the treatment of disease

Examples

Experimental program
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Effect test

example 1

Combination of an OAB Drug and a Salivary Gland Stimulant for the Treatment of Individual with Overactive Bladder

[0114]An individual with overactive bladder is identified. The individual is given 5 mg of oxybutynin two to four times a day in addition to 5 mg of pilocarpine two or three times a day. If the individual continues to complain about dry mouth, the dose of pilocarpine is increased to 10 mg two or three times a day. The dose can be increased up to 20 mg, or 50 mg, if needed. Each dose of oxybutynin can be increased to 10, 15, 20, or 30 mg.

example 2

Combination of an OAB Drug and a Tegaserod for the Treatment of Individual with Overactive Bladder

[0115]An individual with overactive bladder is identified. The individual is given 5 mg of oxybutynin two to four times a day in addition to 2 mg of tegaserod twice a day. If the individual continues to complain about constipation, the dose of tegaserod is increased to 6 mg twice a day. The dose can be increased up to 12 mg, 20 mg, or 50 mg, if needed. The dose of oxybutynin can be increased to 10, 15, 20, or 30 mg.

example 3

Clinical Study Protocol Synopsis

[0116]A study is conducted to evaluate the effect of oxybutynin and pilocarpine, alone and in combination versus placebo on salivary output in healthy volunteers. The objectives of the study are to determine salivary flow and degree of dry mouth after oral administration of oxybutynin and pilocarpine, alone and in combination, vs. placebo, and to determine the effect of oxybutynin and pilocarpine, alone and in combination, on urine volume / void and vital signs.

[0117]At each treatment period, following an overnight fast, subjects enter the clinic and after baseline measurements have been made, they are randomized to one of four medications

[0118]Oxybutynin (5 mg) followed 30 minutes later by placebo

[0119]Pilocarpine (5 mg) followed 30 minutes later by placebo

[0120]Placebo followed 30 minutes later by placebo

[0121]Oxybutynin (5 mg) followed 30 minutes by pilocarpine (5 mg)

[0122]The following measurements are made just prior to and at frequent intervals fo...

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Abstract

Disclosed herein are pharmaceutical compositions comprising various combinations of an antimuscarinic or an anticholinergic agent, a compound that causes stimulation of salivary glands, and a compound that relieves constipation. Also disclosed are methods of treating a patient suffering from overactive bladder comprising administering to the patient the above pharmaceutical composition.

Description

RELATED APPLICATION[0001]This application is a continuation of U.S. application Ser. No. 11 / 467,760, filed, Aug. 28, 2006, by Mehdi Paborji, and entitled “THERAPY FOR THE TREATMENT OF DISEASE,” which in turn claims priority to U.S. Provisional Application No. 60 / 714,150, filed Sep. 2, 2005, by Mehdi Paboiji, and entitled “THERAPY FOR THE TREATMENT OF DISEASE,” both of which are incorporated herein by reference in their entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention is in the field of pharmaceutical compositions and methods of using the same for the treatment of overactive bladder and reduction of various side effects thereof.[0004]2. Description of the Related Art[0005]Overactive bladder (OAB) is characterized by involuntary contractions of the detrusor muscle during bladder filling. These contractions may be asymptomatic or may cause the three common symptoms that clinically define OAB: frequency of urination; urgency; and urge, or re...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/4178A61P25/00
CPCA61K31/00A61K31/137A61K45/06A61K36/72A61K36/68A61K36/482A61K31/216A61K31/4025A61K31/4172A61K31/4178A61K31/439A61K31/46A61K31/717A61K33/06A61K2300/00A61P1/00A61P13/06A61P13/10A61P25/00A61P43/00A61P7/12
Inventor PABORJI, MEHDI
Owner THERAVIDA INC
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