Vivus completes enrollment of phase 2b trial for Alista to treat female sexual dysfunction

By E. Janene Geiss

Philadelphia, Dec. 7 - Vivus Inc. said Wednesday that it completed enrollment in its phase 2b clinical study of its investigational drug Alista (topical alprostadil) for the treatment of female sexual arousal disorder or FSAD.

This phase 2b trial is a multi-center, randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of Alista with a primary endpoint of increased number of satisfactory sexual encounters per month during the 24-week treatment period relative to the initial eight-week baseline period, according to a company news release.

The trial also will measure changes in arousal and distress associated with the patients' FSAD, officials said.

Over 300 women who have undergone a hysterectomy and who have been diagnosed with FSAD were enrolled at 45 centers throughout the United States.

Patients currently enrolled are expected to complete the trial late in 2006, officials said.

"There are currently no FDA-approved therapeutic treatments for FSAD. We believe Alista may provide a viable option for the millions of women who suffer from FSAD," Peter Tam, senior vice president of product and corporate development, said in the release.

Alista is an investigational proprietary formulation of alprostadil applied topically to the female genitalia. It is a synthetic version of prostaglandin E1, a naturally occurring vasodilating agent, and is the same active ingredient found in the Vivius product Muse, which is used to treat male erectile dysfunction. Alista is non-hormonal and is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation, officials said.

Vivus, based in Mountain View, Calif., is a pioneer in the research and development of proprietary products to restore sexual function for women and men. Its product pipeline includes four investigational products in late-stage clinical development.

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