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Details for Patent: 6,113,939

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Details for Patent: 6,113,939

Title: Pharmaceutical compositions for treating priapism and peyronie's syndrome
Abstract:A composition for the treatment of impotence via delivery to the urethra comprises a vasoactive prostaglandin and a polyethylene glycol dispersant having sufficient viscosity to be retained without spillage from a urethra receivable insert. The composition can additionally contain an .alpha.-blocker. Suppositories can be formulated that are small enough for administration to the male urethra, and that dissolve, melt or bioerode within the urethra to release the active agent(s). The suppositories can contain vasodilators other than prostaglandins as the active for the treatment of impotence. Suppositories can also be formulated that contain active agents useful in the treatment of priapism or Peyronie's syndrome.
Inventor(s): Place; Virgil A. (Kawaihae, HI), Gale; Robert M. (Los Altos, CA), Berggren; Randall G. (Livermore, CA)
Assignee: Vivus, Inc. (Mountain View, CA)
Filing Date:Jun 07, 1995
Application Number:08/482,366
Claims:1. A composition for treating priapism and suitable for administration via the urethra, comprising, in unit dosage form, a therapeutic amount of a vasoconstrictor selected from the group consisting of epinephrine, phenylethylamine, norepinephrine, dopamine, metaraminol, phenylephrine, methoxamine, ephedrine, phenylpropanolamine, mephentermine, propylhexedrine, butoxamine, dichloroisoproterenol, propranolol, alprenolol, bunolol, nadolol, oxprenolol, penbutolol, pindolol, sotalol, timolol, metopropolol, atenolol, acebutolol, bevantolol, pafenolol, tolamolol, and combinations thereof, dispersed in a dispersant effective to facilitate delivery of the active agent through the urethra, wherein the composition is in the form of a urethral suppository, and further wherein the therapeutic amount of the vasoconstrictor is effective to treat an individual suffering from priapism when the composition is administered urethrally.

2. The composition of claim 1, wherein the dispersant is selected from the group consisting of polyethylene glycol, propylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyalkyl celluloses, cyclodextrins, glycerol monolaurate, polyethylene glycol monolaurate, and glyceryl monolaurate.

3. The composition of claim 2, wherein the dispersant is selected from the group consisting of polyethylene glycols having molecular weights in the range of approximately 400 to 8000.

4. A composition for treating Peyronie's syndrome and suitable for administration via the urethra, comprising, in unit dosage form, a therapeutic amount of an anti-inflammatory agent 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, testosterone, and combinations thereof, dispersed in a dispersant effective to facilitate delivery of the active agent through the urethra, wherein the composition is in the form of a urethral suppository, and further wherein the therapeutic amount of the anti-inflammatory agent is effective to treat an individual suffering from Peyronie's syndrome when the composition is administered urethrally.

5. The composition of claim 4, wherein the dispersant is selected from the group consisting of polyethylene glycol, propylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyalkyl celluloses, cyclodextrins, glycerol monolaurate, polyethylene glycol monolaurate, and glyceryl monolaurate.

6. The composition of claim 5, wherein the dispersant is selected from the group consisting of polyethylene glycols having molecular weights in the range of approximately 400 to 8000.
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