IP Library Granted Patent US 9,907,767
Granted Patent B2
US 9,907,767 · App. 15/323,685 · Granted Mar 6, 2018

Pharmaceutical compositions and the treatment of overactive bladder

Inventors: Stephen Caltabiano (King of Prussia, PA); Eliot Ohlstein (Glenmore, PA); Stewart McCallum (King of Prussia, PA)
Assignee: Velicept Therapeutics, Inc.
A61K31/196A61K31/216
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Quick Facts
Patent No.
US 9,907,767
App. No.
15/323,685
Granted
Mar 6, 2018
Kind
B2
Abstract

The present invention relates to methods of treating overactive bladder and the symptoms associated therewith, for example, urinary urgency, frequency of mictruitions, 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.

Claims (42)

1. A method of treating overactive bladder in a subject in need thereof, comprising administering a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt, pharmaceutically-acceptable derivative or zwitterion thereof, wherein treating overactive bladder is measured by an increase in voided volume.

2. The method of claim 1 , wherein the solabegron is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients.

3. The method of claim 1 wherein the pharmaceutically-acceptable salt is the hydrochloride salt.

4. The method of claim 1 , wherein the solabegron is a zwitterion.

5. The method of claim 1 wherein the therapeutically effective amount of solabegron is between about 50 mg and about 800 mg.

6. The method of claim 1 , further comprising alleviating one or more of the symptoms of overactive bladder selected from the group consisting of urinary urgency, frequency of mictruitions, nocturia, and urgency urinary incontinence, or a combination thereof.

7. A method of treating overactive bladder in a subject in need thereof, comprising administering a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt, pharmaceutically-acceptable derivative, or zwitterion thereof, wherein the voided volume of the subject is increased.

8. The method of claim 7 , wherein the solabegron is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients.

9. The method of claim 7 , wherein the pharmaceutically-acceptable salt is the hydrochloride salt.

10. The method of claim 7 , wherein the solabegron is a zwitterion.

11. The method of claim 7 , wherein the therapeutically effective amount of solabegron is between about 50 mg and about 800 mg.

12. The method of claim 7 , further comprising alleviating one or more of the symptoms of overactive bladder selected from the group consisting of urinary urgency, frequency of mictruitions, nocturia, and urgency urinary incontinence, or a combination thereof.

13. A method of treating overactive bladder in a subject in need thereof, comprising administering a combination comprising a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt, pharmaceutically-acceptable derivative, or zwitterion thereof; and a therapeutically effective amount, or a sub-therapeutically effective amount, of a muscarinic receptor antagonist or a pharmaceutically-acceptable salt, or pharmaceutically-acceptable derivative thereof, wherein treating overactive bladder is measured by an increase in voided volume.

14. The method of claim 13 , wherein the solabegron is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients.

15. The method of claim 13 , wherein the muscarinic receptor antagonist is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients.

16. The method of claim 13 , wherein the muscarinic receptor antagonist is selected from a group consisting of oxybutynin, tolterodine, solifenacin, trospium, darifenacin, festerodine, hyoscyamine, and propiverine.

17. The method of claim 13 , wherein the muscarinic receptor antagonist is oxybutynin.

18. The method of claim 13 , wherein the solabegron is a hydrochloride salt.

19. The method of claim 13 , wherein the solabegron is a zwitterion.

20. The method of claim 13 , wherein the therapeutically effective amount of solabegron is about 50 mg to about 800 mg.

21. The method of claim 13 , wherein the therapeutically effective amount of the muscarinic receptor antagonist is about 1 mg to about 90 mg.

22. The method of claim 13 , wherein the sub-therapeutically effective amount of the muscarinic receptor antagonist is about 0.1 mg to about 50 mg.

23. The method of claim 13 , wherein the solabegron and the muscarinic receptor antagonist are co-administered.

24. The method of claim 13 , wherein the solabegron and the muscarinic receptor antagonist are contained in a single dosage form, wherein the single dosage form is a pharmaceutical composition.

25. The method of claim 13 , wherein the solabegron and the muscarinic receptor antagonist are administered separately.

26. The method of claim 13 , wherein there is a time delay between the administration of the solabegron and the muscarinic receptor antagonist.

27. The method of claim 13 , further comprising alleviating one or more of the symptoms of overactive bladder selected from the group consisting of urinary urgency, frequency of mictruitions, nocturia, and urgency urinary incontinence, or a combination thereof.

28. A method of treating overactive bladder in a subject in need thereof, comprising administering a combination comprising a therapeutically effective amount of solabegron or a pharmaceutically-acceptable salt, pharmaceutically-acceptable derivative, or zwitterion thereof, and a therapeutically effective amount, or a sub-therapeutically effective amount, of a muscarinic receptor antagonist or a pharmaceutically-acceptable salt thereof, wherein the voided volume of the subject is increased.

29. The method of claim 28 , wherein the solabegron is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients.

30. The method of claim 28 , wherein the muscarinic receptor antagonist is in a pharmaceutical composition comprising one or more pharmaceutically-acceptable carriers, diluents, or excipients.

31. The method of claim 28 , wherein the muscarinic receptor antagonist is selected from a group consisting of oxybutynin, tolterodine, solifenacin, trospium, darifenacin, festerodine, hyoscyamine, and propiverine.

32. The method of claim 28 , wherein the muscarinic receptor antagonist is oxybutynin.

33. The method of claim 28 , wherein the solabegron is a hydrochloride salt.

34. The method of claim 28 , wherein the solabegron is a zwitterion.

35. The method of claim 28 , wherein the therapeutically effective amount of solabegron is about 50 mg to about 800 mg.

36. The method of claim 28 , wherein the therapeutically effective amount of the muscarinic receptor antagonist is about 1 mg to about 90 mg.

37. The method of claim 28 , wherein the sub-therapeutically effective amount of the muscarinic receptor antagonist is about 0.1 mg to about 50 mg.

38. The method of claim 28 , wherein the solabegron and the muscarinic receptor antagonist are co-administered.

39. The method of claim 28 , wherein the solabegron and the muscarinic receptor antagonist are contained in a single dosage form, wherein the single dosage form is a pharmaceutical composition.

40. The method of claim 28 , wherein the solabegron and the muscarinic receptor antagonist are administered separately.

41. The method of claim 28 , wherein there is a time delay between the administration of the solabegron and the muscarinic receptor antagonist.

42. The method of claim 28 , further comprising alleviating one or more of the symptoms of overactive bladder selected from the group consisting of urinary urgency, frequency of mictruitions, nocturia, and urgency urinary incontinence, or a combination thereof.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2021
From: VELICEPT (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC; VELICEPT THERAPEUTICS, INC.
To: B3AR THERAPEUTICS, INC.
Reel/Frame 056285/0273 →
SECURITY INTEREST Recorded Oct 7, 2019
From: VELICEPT THERAPEUTICS, INC.
To: OXFORD FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 050642/0074 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2018
From: OHLSTEIN, ELIOT; MCCALLUM, STEWART; CALTABIANO, STEPHEN
To: VELICEPT THERAPEUTICS, INC.
Reel/Frame 044585/0015 →
Continuity (6)
Continuation In Part PCTUS2015038583 · Jun 30, 2015
Continuation In Part 15235720 · Aug 12, 2016
Continuation 13762563 · Feb 8, 2013
Provisional Application 62020889 · Jul 3, 2014
Provisional Application 61596893 · Feb 9, 2012
Related Publication 20170151199A1 · Jun 1, 2017