Vivus, Inc.

Asivi, LLC

The United States of America, As Represented by the Secretary, Department of Health and Human Services

The United States of America As Represented by the Department of Health

Paul C Doherty, Jr

Virgil A Place

Mark S Hanamoto

Leland F Wilson

Neil Gesundheit

William L Smith

Sean R Bennett

Alfred P Spivack

Larry K Keefer

Joseph E Saavedra

Ibrahim AbouBakr Abdel-Hamid Abdou Ali

Methods and formulations for treating female sexual dysfunction are provided. A pharmaceutical composition formulated so as to contain a selected vasoactive agent is administered to the vagina, vulvar area or urethra of the individual undergoing treatment. Suitable vasoactive agents are vasodilators, including naturally occurring prostaglandins, synthetic prostaglandin derivatives, endothelial-derived relaxation factors, vasoactive intestinal polypeptide agonists, smooth muscle relaxants, leukotriene inhibitors, and others. The formulations are also useful for preventing the occurrence of yeast infections, improving vaginal muscle tone and tissue health, enhancing vaginal lubrication, and minimizing excess collagen deposition. A clitoral drug delivery device is also provided.

Co-administration of a prostaglandin and an androgenic agent in the treatment of female sexual dysfunction

A method is provided for treating erectile dysfunction in a mammalian male individual. The method involves the transmucosal administration of a phosphodiesterase inhibitor or a pharmaceutically acceptable salt, ester, amide or derivative thereof, within the context of an effective dosing regimen. Preferred modes of administration include transbuccal, sublingual and transrectal routes. Pharmaceutical formulations and kits are provided as well.

Transmucosal administration of phosphodiesterase inhibitors for the treatment of erectile dysfunction

Methods and formulations for minimizing excess collagen are provided. A pharmaceutical composition formulated so as to contain a selected vasoactive agent is administered to the vagina, vulvar area or urethra of the individual undergoing treatment. Suitable vasoactive agents are vasodilators, including naturally occurring prostaglandins, synthetic prostaglandin derivatives, endothelial-derived relaxation factors, vasoactive intestinal polypeptide agonists, smooth muscle relaxants, leukotriene inhibitors, and others.

Method for minimizing excess collagen deposition

Treatment of female sexual dysfunction using phosphodiesterase inhibitors

A method is provided for treatment of premature ejaculation by administration of a phosphodiesterase inhibitor, e.g., an inhibitor of a Type III, Type IV, or Type V phosphodiesterase. In a preferred embodiment, administration is on as &ldquo;as needed&rdquo; basis, i.e., the drug is administered immediately or several hours prior to sexual activity. Pharmaceutical formulations and packaged kits are also provided.

Administration of phosphodiesterase inhibitors for the treatment of premature ejaculation

Treatment of female sexual dysfunction

A method of treatment for impotency is provided. The method involves the administration of nitric oxide by a nitric oxide-releasing agent capable of providing a penile erection-inducing amount of nitric oxide to the corpus cavernosum of the penis of an impotent male animal. Also provided is a nitric oxide delivery means for use in the method.

Use of nitric oxide-releasing agents to treat impotency

A method is provided for delaying the onset of ejaculation in an individual. The method preferably involves administration of an antidepressant drug, a serotonin agonist or antagonist, an adrenergic agonist or antagonist, an adrenergic neurone blocker, or a derivative analog thereof, within the context of an effective dosing regimen. The preferred mode of administration is transurethral; however, the selected active agent may also be delivered via intracavernosal injection or using alternative routes. Pharmaceutical formulations and kits are provided as well.

Administration of 5-HT receptor agonists and antagonists, to treat premature ejaculation

A method is provided for treating erectile dysfunction, e.g., vasculogenic erectile dysfunction such as vasculogenic impotence. The method involves the administration of a Type III phosphodiesterase inhibitor or a pharmaceutically acceptable salt, ester, amide or derivative thereof, wherein administration is transurethral, topical or transdermal. A preferred mode of administration is transurethral. Pharmaceutical formulations and kits are provided as well.

Local administration of type III phosphodiesterase inhibitors for the

A method is provided for treating erectile dysfunction, e.g., vasculogenic erectile dysfunction such as vasculogenic impotence. The method involves the administration of a Type IV phosphodiesterase inhibitor or a pharmaceutically acceptable salt, ester, amide or derivative thereof, wherein administration is local, i.e., transurethral, intracavernosal, topical or transdermal. A preferred mode of administration is transurethral. Pharmaceutical formulations and kits are provided as well.

Local administration of Type IV phosphodiesterase inhibitors for the

A method is provided for delaying the onset of ejaculation in an individual. The method involves administration of a 5-HT.sub.3 receptor antagonist within the context of an effective dosing regimen. The preferred mode of administration is transurethral; however, the selected inhibitor may also be delivered via intracavernosal injection or using alternative routes.

Administration of 5-HT.sub.3 receptor antagonists to treat premature

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.

Local administration of phosphodiesterase inhibitors for the treatment

A method for treating peripheral vascular disease (PVD), related vascular diseases, and vascular impotence associated with such diseases, is provided. The method involves transurethral administration of a pharmaceutical formulation containing a selected vasoactive agent within the context of an effective dosing regimen. Preferred vasoactive agents are vasodilating agents selected from the group consisting of naturally occurring prostaglandins, synthetic prostaglandin derivatives, and combinations thereof. The pharmaceutical formulations used in conjunction with the novel method may also contain enzyme inhibitors, transurethral permeation enhancers, carriers, preservatives, surfactants, and the like. Kits and pharmaceutical formulations are provided as well.

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Cupertino, CA, United States of America

Paul C Doherty, Jr