Pharmaceutical compositions and the treatment of overactive bladder

Abstract

The present invention relates to methods of treating overactive bladder and the symptoms associated therewith, for example, urinary urgency, frequency of micturitions, nocturia, and urgency urinary incontinence. One treatment method according to the present invention comprises treatment with the beta-3 adrenergic receptor agonist solabegron. Another treatment combination according to the invention comprises solabegron, and a muscarinic receptor antagonist which results in a synergistic effect on the symptoms associated with OAB.

1 - 42 . (canceled) 
     
     
         43 . A method of treating overactive bladder in a human in need thereof comprising orally administering to the human a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt thereof, wherein treating overactive bladder is treating an increase in nocturia. 
     
     
         44 . The method of  claim 43 , wherein treating an increase in nocturia is measured by a percent change from baseline in nocturia episodes. 
     
     
         45 . The method of  claim 43 , wherein treating an increase in nocturia results in a decrease in nocturia. 
     
     
         46 . The method of  claim 43 , wherein the solabegron or the pharmaceutically-acceptable salt thereof is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients. 
     
     
         47 . The method of  claim 46 , wherein the pharmaceutical composition is selected from a capsule, a tablet, a powder, a granule, a solution, a suspension, an edible foam, an edible whip, an oil-in-water liquid emulsion or a water-in-oil liquid emulsion. 
     
     
         48 . The method of  claim 46 , wherein the pharmaceutical composition is a tablet. 
     
     
         49 . The method of  claim 43 , wherein the pharmaceutically-acceptable salt is the hydrochloride salt. 
     
     
         50 . The method of  claim 43  further comprising treating one or more of symptoms of overactive bladder selected from the group consisting of urinary urgency, micturition frequency, urinary incontinence, and a combination thereof. 
     
     
         51 . A method of treating overactive bladder in a human in need thereof consisting of orally administering to the human a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt thereof, wherein treating overactive bladder is treating an increase in nocturia. 
     
     
         52 . The method of  claim 51 , wherein treating an increase in nocturia is measured by a percent change from baseline in nocturia episodes. 
     
     
         53 . The method of  claim 51 , wherein treating an increase in nocturia results in a decrease in nocturia. 
     
     
         54 . The method of  claim 51 , wherein the solabegron or the pharmaceutically-acceptable salt thereof is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients. 
     
     
         55 . The method of  claim 54 , wherein the pharmaceutical composition is selected from a capsule, a tablet, a powder, a granule, a solution, a suspension, an edible foam, an edible whip, an oil-in-water liquid emulsion or a water-in-oil liquid emulsion. 
     
     
         56 . The method of  claim 54 , wherein the pharmaceutical composition is a tablet. 
     
     
         57 . The method of  claim 51 , wherein the pharmaceutically-acceptable salt is the hydrochloride salt. 
     
     
         58 . The method of  claim 51  further comprising treating one or more of symptoms of overactive bladder selected from the group consisting of urinary urgency, micturition frequency, urinary incontinence, and a combination thereof. 
     
     
         59 . A method of treating overactive bladder in a human in need thereof comprising orally administering to the human a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt thereof, wherein treating overactive bladder is treating an increase in urgency urinary incontinence. 
     
     
         60 . The method of  claim 59 , wherein treating an increase in urgency urinary incontinence is measured by a percent change from baseline in urgency urinary incontinence episodes. 
     
     
         61 . The method of  claim 59 , wherein treating an increase in urgency urinary incontinence results in a decrease in urgency urinary incontinence. 
     
     
         62 . The method of  claim 59 , wherein the solabegron or the pharmaceutically-acceptable salt thereof is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients. 
     
     
         63 . The method of  claim 62 , wherein the pharmaceutical composition is selected from a capsule, a tablet, a powder, a granule, a solution, a suspension, an edible foam, an edible whip, an oil-in-water liquid emulsion or a water-in-oil liquid emulsion. 
     
     
         64 . The method of  claim 62 , wherein the pharmaceutical composition is a tablet. 
     
     
         65 . The method of  claim 59 , wherein the pharmaceutically-acceptable salt is the hydrochloride salt. 
     
     
         66 . The method of  claim 59  further comprising treating one or more of symptoms of overactive bladder selected from the group consisting of urinary urgency, micturition frequency, nocturia, and a combination thereof. 
     
     
         67 . A method of treating overactive bladder in a human in need thereof consisting of orally administering to the human a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt thereof, wherein treating overactive bladder is treating an increase in urgency urinary incontinence. 
     
     
         68 . The method of  claim 67 , wherein treating an increase in urgency urinary incontinence is measured by a percent change from baseline in urgency urinary incontinence episodes. 
     
     
         69 . The method of  claim 67 , wherein treating an increase in urgency urinary incontinence results in a decrease in urgency urinary incontinence. 
     
     
         70 . The method of  claim 67 , wherein the solabegron or the pharmaceutically-acceptable salt thereof is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients. 
     
     
         71 . The method of  claim 70 , wherein the pharmaceutical composition is selected from a capsule, a tablet, a powder, a granule, a solution, a suspension, an edible foam, an edible whip, an oil-in-water liquid emulsion or a water-in-oil liquid emulsion. 
     
     
         72 . The method of  claim 70 , wherein the pharmaceutical composition is a tablet. 
     
     
         73 . The method of  claim 67 , wherein the pharmaceutically-acceptable salt is the hydrochloride salt. 
     
     
         74 . The method of  claim 67  further comprising treating one or more of symptoms of overactive bladder selected from the group consisting of urinary urgency, micturition frequency, nocturia, and a combination thereof.