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Claims for Patent: 5,474,535

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Claims for Patent: 5,474,535

Title: Dosage and inserter for 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 (40) having a shaft with a deformable distal end which forms a dose receiving cavity when an internal piston is retracted relative to the shaft.
Inventor(s): Place; Virgil A. (Kawaihae, HI), Gale; Robert M. (Los Altos, CA), Berggren; Randall G. (Livermore, CA)
Assignee: Vivus, Inc. (Menlo Park, CA)
Application Number:08/093,545
Patent Claims: 1. A dosage form for treating an erectile dysfunction, said dosage form comprising, in combination:

a) a shaft having a diameter that is receivable in the male urethra, said shaft having a proximal end and a blunted distal end;

b) means to prevent complete insertion of said shaft into the urethra on the proximal end of said shaft; and

c) a dose of a therapeutic composition for said erectile dysfunction carried in said shaft prior to insertion in the urethra, said therapeutic composition comprising a therapeutic agent for said erectile dysfunction, wherein said dose weighs less than about 100 mgs, is solid at ambient temperature, and is capable of being dissolved, absorbed, melted or bioeroded in the urethra.

2. The dosage form of claim 1 further comprising:

d) a cavity containing said therapeutic composition at the blunted distal end of said shaft.

3. The dosage form of claim 2 further comprising:

e) means for displacing said composition from said cavity into the urethra.

4. The dosage form of claim 1 wherein said therapeutic composition is positioned in said shaft to be deposited within the urethra between the proximal portion of the fossa navicularis and the distal position of the pendulous urethra.

5. The dosage form of claim 1 wherein said dose weighs not more than 50 mg of agent.

6. The dosage form of claim 1, 2, 3, 4, or 5 wherein said shaft is from about 2-5 cm in length.

7. The dosage form of claim 1, 2, 3, 4, or 5 wherein said composition comprises a urethral permeation enhancer for said agent.

8. The dosage form of claim 1, 2, 3, 4, or 5 wherein said erectile dysfunction is impotence and said agent comprises one or more vasodilators.

9. The dosage form of claim 8 wherein said vasodilators are selected from the group consisting of nitrates, long and short acting .alpha.-blockers, calcium blockers, ergot alkaloids, chlorpromazine, haloperidol, yohimbine, natural and synthetic vasoactive prostaglandins and their analogs, vasoactive intestinal peptides, dopamine agonists, opioid antagonists and mixtures thereof.

10. The dosage form of claim 8 wherein said agent comprises an .alpha.-blocker and a prostaglandin.

11. The dosage form of claim 8 wherein said agent is selected from the group consisting of about 10-2000 .mu.g of a vasoactive prostaglandin, 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 therapeutic composition further comprises polyethylene glycol and said agent comprises an .alpha.-blocker and a prostaglandin.

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

14. The dosage form of claim 1, 2, 3, 4 or 5 wherein said dysfunction is priapism and said agent comprises one or more vasoconstrictors.

15. The dosage form of claim 1, 2, 3, 4 or 5 wherein said dysfunction is Peyronie's syndrome and said agent comprises a material selected from the group consisting of steroidal and nonsteroidal anti-inflammatory agents and mixtures thereof.

16. The dosage form of claim 1, 2, 3, 4 or 5 wherein said dysfunction is priapism and said agent is selected from the group consisting of .alpha.-agonists and .beta.-blockers and mixtures thereof.

17. The dosage form of claim 1, 2, 3, 4, 5 or 11 wherein said therapeutical composition further comprises polyethylene glycol.

18. A dosage form for treating erectile dysfunction, said dosage form comprising, in combination:

a) an insert comprising:

(i) a shaft having a proximal end and a distal end sized to be received within the male urethra; and

(ii) a bore within said shaft;

b) a piston slidably received within said bore and movable from a first position where said piston forms a dose receiving cavity proximate to the distal end of said shaft to a second position where said dose is displaced from said cavity; and

c) a dose of a therapeutic composition for said erectile dysfunction comprising said therapeutic agent for said erectile dysfunction, said dose being received in said cavity, wherein said dose is solid at ambient temperature, and is capable of being dissolved, absorbed, melted or bioeroded in the urethra.

19. The dosage form of claim 18 wherein:

A. the shaft of said insert is closed at said distal end to form a flexible peripheral wall having an interior surface and an exterior surface; and

B. said piston is attached to the interior surface of said peripheral wall, said piston in said first position being withdrawn within said shaft where said flexible peripheral wall forms said cavity enclosing said dose.

20. The dosage form of claim 18 wherein said dose weighs less than about 50 mg.

21. The dosage form of claim 20 wherein the length of said shaft potion is from 2-5 cm.
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