VIVUS Announces Results Of ALISTA Phase 2b Study

Main Category: Women's Health / Gynecology
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 Sep 2006 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

VIVUS, Inc. (Nasdaq: VVUS), today announced results of the company's Phase 2b clinical study of its investigational drug ALISTA(TM) (topical alprostadil), for the treatment of female sexual arousal disorder (FSAD), in women who have undergone a hysterectomy. In this double-blind, placebo-controlled study, patients with FSAD using ALISTA achieved a more than doubling over baseline in the number of satisfactory sexual events; however, the difference between the ALISTA treatment group and the placebo group did not achieve statistical significance for the primary endpoint of the study. Following a 2-month non-treatment run-in period, 320 subjects were randomly assigned to treatment with ALISTA or placebo for a period of 6 months. During study participation, subjects maintained daily diaries to capture outcomes of all sexual encounters, and the primary measure of treatment efficacy was based on the difference between ALISTA and placebo in the improvement over baseline in the number of satisfactory sexual encounters per month. This was the first study in which the efficacy of ALISTA was prospectively evaluated in an all organically impaired group of patients with FSAD.

"The placebo response rate was higher than what was anticipated in this phase 2b trial," said Leland Wilson, president and CEO of VIVUS.

"Additional work will be required to determine how to better control the placebo response rate in this patient population before additional clinical trials can be started. Because we have a rich pipeline with three late-stage development programs, ALISTA will receive a lower development priority at VIVUS. We will focus our development efforts on Qnexa for the treatment of obesity, Testosterone MDTS for the treatment of hypoactive sexual desire disorder (HSDD) and avanafil for the treatment of male erectile dysfunction (MED), all of which have demonstrated clear, clinical and statistical significance over placebo in phase 2 studies."

About VIVUS

VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has three products that are positioned to enter Phase 3 clinical trials, and one product that has completed Phase 3 evaluation, for which an NDA is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in the second half of 2006. The investigational pipeline includes: Qnexa(TM), for which a Phase 2 study has been completed for the treatment of obesity; Testosterone MDTS(R), for which a Phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); Evamist(TM), for which a Phase 3 study has been completed for the treatment of menopausal symptoms; avanafil, for which a Phase 2 study has been completed for the treatment of erectile dysfunction (ED); and, MUSE(R), which is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at http://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, 2005 and periodic reports filed with the Securities and Exchange Commission.

VIVUS, Inc
http://www.vivus.com