Local administration of phosphodiesterase inhibitors for the treatment of erectile dysfunction
AssigneeVivus, Inc.
InventorsPaul C. Doherty, Jr., Virgil A. Place, William L. Smith
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Abstract
A method is provided for treating erectile dysfunction in a mammalian male individual. The method involves the local administration of a phosphodiesterase inhibitor or a pharmaceutically acceptable salt, ester, amide or derivative thereof within the context of an effective dosing regimen. A preferred mode of administration is transurethral. Pharmaceutical formulations and kits are provided as well.
Claims94
A method for treating erectile dysfunction in a male individual, comprising locally administering to the individual an effective amount of a pharmaceutical composition consisting essentially of a Type V, cGMP-specific phosphodiesterase inhibitor or a pharmaceutically acceptable salt, ester, amide or prodrug thereof.
A pharmaceutical formulation for treating erectile dysfunction in an individual, comprising a urethral dosage form of a phosphodiesterase inhibitor, a carrier suitable for transurethral drug administration, and, optionally, a transurethral permeation enhancer, wherein the phosphodiesterase inhibitor is a Type V, cGMP-specific phosphodiesterase inhibitor, or a pharmaceutically acceptable salt ester, amide or prodrug thereof.
A pharmaceutical formulation for treating erectile dysfunction in an individual comprising a sterile liquid composition suitable for intracavernosal administration containing a therapeutically effective amount of a phosphodiesterase inhibitor and a carrier suitable for intracavemosal injection, wherein the phosphodiesterase inhibitor is a Type V, cGMP-specific phosphodiesterase inhibitor, or a pharmaceutically acceptable salt, ester, amide or prodrug thereof.
A pharmaceutical formulation for treating erectile dysfunction in an individual, comprising a topical or transdermal composition containing a therapeutically effective amount of a phosphodiesterase inhibitor and a carrier suitable for administration of a drug to the skin or mucosal tissue, wherein the phosphodiesterase inhibitor is a Type V, cGMP-specific phosphodiesterase inhibitor, or a pharmaceutically acceptable salt, ester, amide or prodrug thereof.
A kit for treating erectile dysfunction in an individual, comprising:
- a urethral dosage form of a Type V, cGMP-specific phosphodiesterase inhibitor or a pharmaceutically acceptable salt ester, amide or prodrug thereof;
- a means for transurethrally administering the agent;
- a container for housing the formulation and drug delivery means;
- and instructions for using the drug delivery means to administer the drug within the context of a dosing regimen effective to treat erectile dysfunction.
A method for treating erectile dysfunction in a male individual, comprising administering to the individual a pharmaceutical composition comprising a therapeutically effective amount of:
- (a) a phosphodiesterase inhibitor selected from the group consisting of Type V, cGMP-specific phosphodiesterase inhibitors and pharmaceutically acceptable salts, esters, amides and prodrugs thereof;
- and (b) an additional active agent selected from the group consisting of (i) nitric oxide donors, (ii) prostaglandins, (iii) ergot alkaloids, (iv) .alpha.-blockers, (v) vasoactive intestinal peptide, (vi) antihypertensive agents, (vii) vasodilators, (viii) chlorpromazine, (ix) haloperidol, (x) yohimbine, (xi) Rec15/2739, (xii) trazodone, and pharmaceutically acceptable salts, esters, amides and prodrugs thereof, and wherein administration is transurethral, topical or transdermal.
Dependencies are inferred from the claim text.