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Claims for Patent: 5,773,020

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Claims for Patent: 5,773,020

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. (Mountain View, CA)
Application Number:08/959,739
Patent Claims: 1. A dosage form for treating an erectile dysfunction comprising a shaft sized to be received within the male urethra and a composition retained within said shaft comprising an effective amount of a vasoactive prostaglandin and at least one dispersant.

2. The dosage form of claim 1 wherein said composition weighs not more than about 50 mg.

3. The dosage form of claim 2 wherein dysfunction is impotence and said agent consists of a mixture of from about 10-1000 .mu.g of alprostadil and 50-1000 .mu.g of prazosin.

4. The dosage form of claim 1 wherein said composition comprises a urethral permeation enhancer for said agent.

5. The dosage form of claim 1 wherein said agent comprises one or more vasodilators in addition to said vasoactive prostaglandin.

6. The dosage form of claim 1 wherein said vasoactive prostaglandin is prostaglandin E.sub.1.

7. The dosage form of claim 1 wherein said vasoactive prostaglandin in prostaglandin E.sub.2.

8. The dosage form of claim 1 wherein said dispersant is selected from the group consisting of pharmaceutically acceptable materials which dissolve, melt or bioerode within the urethra to release the agent.

9. The dosage form of claim 5 wherein said vasodilators are selected from the group consisting of nitrates, long and short acting .alpha.-blockers, calcium blockers, ergot alkaloids, chlorpromazine, haloperidol, yohimbine, vasoactive intestinal peptides, dopamine agonists, opioid antagonists and mixtures thereof.

10. The dosage form of claim 1 wherein said vasodilator is an .alpha.-blocker.

11. The dosage form of claim 5 wherein said agent comprises about 10-2000 .mu.g of a vasoactive prostaglandin and at least one vasodilator selected from the group consisting of about 1-50 mg of papaverine, about 1-10 mg of phentolamine, about 50-2000 .mu.g of prazosin, about 50-2000 .mu.g of doxazosin about 50-2000 .mu.g of terazosin and mixtures thereof.

12. The dosage form of claim 11 wherein said agent comprises about 10-2000 .mu.g of a vasoactive prostaglandin.

13. The dosage form of claim 1 wherein said dispersant is selected from the group consisting of polyethylene glycol, propylene glycol, glycerine, polyvinyl pyrrolidine, polyvinyl alcohol, hydroxy alkyl celluloses, and cyclodextrins.

14. The dosage form of claim 1 wherein said dispersant comprises polyethylene glycol.

15. The dosage form of claim 1 wherein said dispersant comprises a cyclodextrin.

16. The dosage form of claim 12 wherein said vasoactive prostaglandin is selected from the group consisting of natural and synthetic prostaglandins, prostaglandin E.sub.1, alprostadil, misoprostol, enprostil, prostaglandin E.sub.2, and analogs thereof.

17. The dosage form of claim 11 wherein said agent consists essentially of alprostadil and prazosin.

18. The dosage form of claims 1 wherein said composition is present in an amount less than about 100 mg.
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