Vivus, Inc.

Asivi, LLC

Leland F Wilson

Peter Y Tam

Virgil A Place

Neil Gesundheit

Paul C Doherty, Jr

Thomas Najarian

Mark S Hanamoto

Sean R Bennett

Alfred P Spivack

Craig Peterson

William L Smith

Thomas Najaraian

Ibrahim AbouBakr Abdel-Hamid Abdou Ali

The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.

Escalating dosing regimen for effecting weight loss and treating obesity

A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.

Low dose topiramate/phentermine composition and methods of use thereof

This disclosure relates generally to methods and pharmaceutical compositions useful in treating pulmonary hypertension. In one embodiment, for example, the disclosure provides a method for treating pulmonary hypertension comprising administering a therapeutically effective dose of a carbonic anhydrase inhibitor to a patient in need of treatment. The disclosure finds utility in the fields of medicine and pharmacology.

Treatment of pulmonary hypertension with carbonic anhydrase inhibitors

Methods for treating female sexual dysfunction are provided. A pharmaceutical composition containing a vasoactive agent selected from vasoactive intestinal potypeptide (VIP) and VIP agonists is administered to the vagina and/or vulvar region of the individual undergoing treatment. The formulations are also useful for improving vaginal muscle tone and tissue health, enhancing vaginal lubrication, and minimizing excess collagen deposition. Pharmaceutical formulations and kits are also provided.

Treatment of female sexual dysfunction with vasoactive intestinal polypeptide agonists

A method is provided for treatment of premature ejaculation by administration of an antidepressant drug selected from tricyclic antidepressants, tetracyclic antidepressants, MAO inhibitors, azaspirone antidepressants, and atypical non-SRI antidepressants. In a preferred embodiment, administration is on as 'as-needed' basis, i.e., the drug is administered immediately or at most several hours prior to sexual activity. Pharmaceutical formulations and packaged kits are also provided.

As-needed administration of tricyclic and other non-SRI antidepressant drugs to treat premature ejaculation

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 delaying the onset of ejaculation in an individual. The method involves systemic and on demand administration to an individual of a pharmaceutical formulation containing an amount of an active agent selected from the group consisting of clomipramine and pharmacologically acceptable acid addition salts thereof. Drug delivery may be accomplished via any route designed to provide systemic levels of the active agent effective to delay the onset of ejaculation. Pharmaceutical formulations and dosage forms are provided as well.

On demand administration of clomipramine and salts thereof to treat premature ejaculation

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.

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Menlo Park, CA, United States of America

Leland F Wilson