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Details for Patent: 6,093,181

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Details for Patent: 6,093,181

Title: Treatment of erectile dysfunction
Abstract:Erectile dysfunction, particularly impotence, priapism and Peyronie's disease is treated by the transurethral administration of a therapeutically effective agent. The agents are administered to the urethra by means of a penile insert (1) having a rapidly releasing coating (4) containing the agent on its exterior surface or by means of an inserter (27) carrying an agent containing dose of agent (31) which can be displaced into the urethra.
Inventor(s): Place; Virgil A. (Kawaihae, HI), Gale; Robert M. (Los Altos, CA), Berggren; Randall G. (Livermore, CA)
Assignee: Vivus, Inc. (Moutain View, CA)
Filing Date:Jun 07, 1995
Application Number:08/481,738
Claims:1. A method for treating priapism which comprises introducing into the urethra of a male patient suffering from priapism an amount of a composition comprising (a) a dosage of an active agent effective for treating priapism, wherein the active agent comprises a vasoconstrictor selected from the group consisting of .alpha.-agonists and .beta.-blockers and (b) a dispersant in which the active agent is dispersed, wherein the dispersant is effective to facilitate delivery of the active agent through the urethra such the active agent ultimately reaches the corpora cavernosa and is selected from the group consisting of pharmaceutically acceptable materials which dissolve, melt or bioerode within the urethra to release the agent, and further wherein the composition is in the form of a paste, gel, cream or suppository.

2. The method of claim 1, wherein the composition is administered into the urethra at a depth of at least about 1 cm.

3. The method of claim 1, wherein the composition is administered into the urethra at a depth in the range of approximately 2 cm to 5 cm.

4. The method of claim 1, wherein said dispersant is selected from the group consisting of polyethylene glycol, propylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxy alkyl celluloses, cyclodextrins, glycerol monolaurate, polyethylene glycol monolaurate, glycerol monolaurate, and mixtures thereof.

5. The method of claim 4, wherein said dispersant is selected from the group consisting of polyethylene glycol, propylene glycol, cyclodextrins, and mixtures thereof.

6. The method of claim 5, wherein said dispersant is comprised of polyethylene glycol.

7. The method of claim 6, wherein said dispersant is comprised of a mixture of polyethylene glycols having different molecular weights.

8. The method of claim 7, wherein said dispersant is comprised of polyethylene glycol or a mixture of polyethylene glycols having molecular weights in the range of about 400 to 8000.

9. The method of claim 6, wherein said dispersant comprises polyethylene glycol having a molecular weight of about 1450.

10. The method of claim 1, wherein said composition is in the form of a gel, cream, or suppository.

11. The method of claim 10, wherein said composition is in the form of a suppository.

12. The method of claim 1, wherein said composition additionally comprises a urethral permeation enhancer for said agent.

13. The method of claim 1, wherein said vasoconstrictor comprises an .alpha.-agonist.

14. The method of claim 13, wherein the vasoconstrictor is selected from the group consisting of epinephrine, phenylethylamine, norepinephrine, dopamine, metaraminol, phenylephrine, methoxamine, ephedrine, phenylpropanolamine, mephentermine, propylhexedrine, and combinations thereof.

15. The method of claim 1, wherein said vasoconstrictor comprises a .beta.-blocker.

16. The method of claim 15, wherein the vasoconstrictor is selected from the group consisting of butoxamine, dichloroisoproterenol, propranolol, alprenolol, bunolol, nadolol, oxprenolol, penbutolol, pindolol, sotalol, timolol, metopropolol, atenolol, acebutolol, bevantolol, pafenolol, tolamolol, and combinations thereof.

17. A method for treating Peyronie's syndrome which comprises introducing into the urethra of a male patient suffering from Peyronie's syndrome an amount of a composition comprising (a) a dosage of an active agent effective for treating Peyronie's syndrome, wherein the active agent comprises an anti-inflammatory agent, dispersed in (b) a dispersant effective to facilitate delivery of the active agent through the urethra such the active agent ultimately reaches the corpora cavernosa and selected from the group selected from the group consisting of pharmaceutically acceptable materials which dissolve, melt or bioerode within the urethra to release the agent, and further wherein the composition is in the form of a paste, gel, cream or suppository.

18. The method of claim 17, wherein said anti-inflammatory agent is selected from the group consisting of cortisone, hydrocortisone, tetrahydrocortisone, prednisone, prednisolone, methyl prednisolone, fludrocortisone, desoxycortisol, corticosterone, triamcinolone, paramethasone, betamethasone, dexamethasone, beclomethasone, salicylic acid, aspirin, diflunisal, methyl salicylate, phenylbutazone, oxyphenbutazone, apazone, phenacetin, acetaminophen, indomethacin, sulindac, mefenamic acid, meclofenamate sodium, tolmetin, ibuprofen, naproxen, fenoprofen, and combinations thereof.

19. The method of claim 17, wherein the composition is administered into the urethra at a depth of at least about 1 cm.

20. The method of claim 17, wherein the composition is administered into the urethra at a depth in the range of approximately 2 cm to 5 cm.

21. The method of claim 17, wherein said dispersant is selected from the group consisting of polyethylene glycol, propylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxy alkyl celluloses, cyclodextrins, glycerol monolaurate, polyethylene glycol monolaurate, glycerol monolaurate, and mixtures thereof.

22. The method of claim 21, wherein said dispersant is selected from the group consisting of polyethylene glycol, propylene glycol, cyclodextrins, and mixtures thereof.

23. The method of claim 22, wherein said dispersant is comprised of polyethylene glycol.

24. The method of claim 23, wherein said dispersant is comprised of a mixture of polyethylene glycols having different molecular weights.

25. The method of claim 24, wherein said dispersant is comprised of polyethylene glycol or a mixture of polyethylene glycols having molecular weights in the range of about 400 to 8000.

26. The method of claim 23, wherein said dispersant comprises polyethylene glycol having a molecular weight of about 1450.

27. The method of claim 17, wherein said composition is in the form of a gel, cream, or suppository.

28. The method of claim 27, wherein said composition is in the form of a suppository.

29. The method of claim 17, wherein said composition additionally comprises a urethral permeation enhancer for said agent.
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