VIVUS, Inc. is a specialty pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. The Company has been working diligently with Tanabe with respect to the manufacture of, and analytical assay development for, TA-1790,its oral phosphodiesterase type 5 inhibitor for treatment of male erectile dysfunction (MED). Phosphodiesterase type 5 is the same enzyme inhibited by sildenafil, the active ingredient in Viagra(R). It is the goal of VIVUS to initiate clinical studies with an oral version of TA-1790 for treatment of ED, while at the same time establishing a program to evaluate the feasibility of a transurethral formulation of the compound.
VIVUS continues to aggressively pursue approval for ALIBRA(R) with the U.S. Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products.
Female Sexual Dysfunction
A Phase II study to evaluate the effects of topical ALISTA(TM) in female sexual arousal disorder (FSAD) is ongoing. This is a multi-center, double-blind trial designed to evaluate the safety and potential efficacy of ALISTA in women with FSAD. Completion of the dosing portion of the study is expected in the third quarter of the year. Upon completion of this trial, the Company plans to initiate expanded Phase II studies.
Premature Ejaculation
VIVUS continues the development of VI-0134, its oral, on-demand product for treatment of premature ejaculation (PE). The Company has developed a revised formulation of VI-0134, designed to improve the absorption of the compound. Plans are to initiate clinical testing of this new formulation in humans by the end of the year.
About VIVUS
VIVUS, Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE: ABT) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS is partnered exclusively with Paladin Labs, Inc. (TSE: PLB) to market and distribute MUSE. estors: Additional written materials,recent releases and Company information are available through a variety of sources, including the VIVUS home page (www.vivus.com) and the VIVUS Fax-On-Demand Service (1-888-329-5719).
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