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VIVUS COMPLETES DOSING IN PHASE II FOR FEMALE SEXUAL DYSFUNCTION.

VIVUS Inc. (Nasdaq:VVUS), Mountain View, Calif., has completed patient dosing in a Phase II study of the company's Female Sexual Dysfunction (FSD) product, ALISTA(TM).

The study, initiated earlier this year, is being conducted to evaluate the safety and potential efficacy of topically applied ALISTA in subjects with Female Sexual Arousal Disorder (FSAD). Results of the double-blind trial will be analyzed in the upcoming months.

Following analysis of the data, the company expects to initiate additional Phase II studies to evaluate the safety and efficacy of ALISTA in the home setting.

"The Journal of the American Medical Association reported that 43% of women of all ages experience some form of sexual dysfunction. We have made significant progress in developing ALISTA for this major market. We believe we are on the mark to continue this development program according to the schedule we set for ourselves," commented Dr. John Dietrich, vice president of Research and Development.

ALISTA is a proprietary formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of prostaglandin E1 (PGE1), a naturally occurring vasodilating agent. It is the same active ingredient found in VIVUS' product MUSE(R), which is used to treat male erectile dysfunction.

ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation. With both issued and pending patents, the company believes it has the dominant patent position for the local delivery of prostaglandins, such as alprostadil, in the treatment of women with FSD.

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 developed and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R) (recently cleared for OTC marketing) -- 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 has partnered exclusively with Paladin Labs to market and distribute MUSE. The company also has development programs for TA-1790, a highly selective PDE5 inhibitor compound for both oral and local treatment of sexual dysfunction in men and women. In addition, VIVUS is developing VI-0134 for the potential treatment of premature ejaculation.

For more information, call 650/934-5264 or visit http:// www.vivus.com.
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Comment:VIVUS COMPLETES DOSING IN PHASE II FOR FEMALE SEXUAL DYSFUNCTION.
Publication:Biotech Business
Geographic Code:1USA
Date:Oct 1, 2001
Words:400
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