MOUNTAIN VIEW, Calif., Dec. 7 /PRNewswire-FirstCall/ -- VIVUS Inc. today announced it completed enrollment in its Phase 2b clinical study of its investigational drug ALISTA(TM) (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. The primary endpoint is the increase in the number of satisfactory sexual encounters per month during the 24-week treatment period relative to the initial 8-week baseline period. The trial will also measure changes in arousal and distress associated with the patients’ FSAD. 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.
“Completion of enrollment in the Phase 2b trial for ALISTA represents yet another corporate milestone for VIVUS and the last important milestone for 2005,” said Peter Tam, Senior Vice President of Product and Corporate Development of VIVUS. “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.”
About ALISTA
ALISTA is an investigational proprietary formulation of alprostadil applied topically 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 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. With both issued and pending patents, the Company believes it has a dominant patent position for the local delivery of prostaglandins, such as alprostadil, for the treatment of women with FSAD. FSAD is one of the most common sexual problems experienced by women. The disorder is characterized by diminished blood flow to the genital tissues resulting in a lack of genital engorgement and a reduction in pleasure and sensation during sexual stimulation.
About VIVUS
VIVUS Inc. is a pioneer in the research and development of proprietary products to restore sexual function for women and men. VIVUS’ current product pipeline includes four investigational products in late stage clinical development. For women, VIVUS has initiated a Phase 2b program with ALISTA(TM) for female sexual arousal disorder, and a Phase 3 program for Evamist(TM) for the alleviation of menopausal symptoms. VIVUS has completed Phase 2 development for Testosterone MDTS(R) for the treatment of hypoactive sexual desire disorder (HSDD). The MDTS system is a patented new-generation, transdermal drug delivery technology that delivers drugs through the skin. For men, VIVUS is developing avanafil for erectile dysfunction, which has completed Phase 2 development. VIVUS currently markets MUSE(R) (alprostadil) suppository for the treatment of erectile dysfunction in the U.S. and internationally through distributors. For more information on clinical trials and products, please visit the Company’s web site at www.vivus.com .
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2004 and periodic reports filed with the Securities and Exchange Commission.
For more information: VIVUS Inc. Timothy E. Morris Chief Financial Officer 650-934-5200
VIVUS Inc.
CONTACT: Timothy E. Morris, Chief Financial Officer of VIVUS Inc.,+1-650-934-5200
Web site: http://www.vivus.com//