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US 9,956,194 B2Granted
Compositions and methods of using modified release solabegron for lower urinary tract symptoms
AssigneeVelicept Therapeutics, Inc.
InventorsEliot Ohlstein, Raymond E. Stevens, Jr., H. Jeffrey Wilkins
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Abstract
This application relates to pharmaceutical compositions, comprising solabegron that are useful for the treatment of lower urinary tract symptoms such as, for example, overactive bladder and prostate disorders. Additionally, this application relates to methods for treating lower urinary tract symptoms utilizing the pharmaceutical compositions, comprising solabegron. In some embodiments, the pharmaceutical compositions, comprising solabegron comprise a dual release drug delivery system.
Claims60
A method for treating LUTS in a patient in need thereof, comprising:
- administering once a day to the patient a pharmaceutical composition for the delivery of a therapeutically effective amount of solabegron, comprising:
- an immediate release composition, comprising solabegron and at least one pharmaceutically acceptable carrier or diluent;
- and a delayed release composition, comprising solabegron and at least one pharmaceutically acceptable carrier or diluent to the patient, wherein the immediate release composition achieves a first plasma Cmax, the delayed release composition achieves a second plasma Cmax, a first plasma Cmin is achieved after the first plasma Cmax and before the second plasma Cmax and a second plasma Cmin is achieved after the second plasma Cmax;
- wherein the first plasma Cmax is about 0.5 ug/ml to about 4.0 ug/ml in about 0.75 to about 4 hours after administration of the pharmaceutical composition;
- wherein the first plasma Cmin is about 0.25 ug/ml to about 1.5 ul/ml in about 4 to about 8 hours after administration of the pharmaceutical composition;
- wherein the second plasma Cmax is about 0.5 ug/ml to about 4 ug/ml in about 2 to about 8 hours after the first plasma Cmin;
- wherein the second plasma Cmin is about 0.01 ug/ml to about 1.0 ug/ml before about 24 hours after administration of the pharmaceutical composition;
- wherein the pharmaceutical composition reduces desensitization of the beta-3 adrenoceptor, when compared to an immediate release pharmaceutical composition of solabegron administered twice daily.
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Dependencies are inferred from the claim text.