Vivus, Inc.: VVUS (NASDAQ)
Positive Results from Phase II Trial for ALISTA(TM) for Female Sexual Dysfunction to Be Presented at 2002 Annual Meeting of the American Urological Association
First Data Demonstrating Drug Can Improve Sexual Arousal and Satisfaction in Women
MOUNTAIN VIEW, Calif.--May 22, 2002--VIVUS, Inc. (Nasdaq:VVUS), will present detailed data from its Phase II clinical trial of ALISTA(TM), its proprietary topical formulation of alprostadil for the treatment of Female Sexual Arousal Disorder (FSAD), at the Annual Meeting of the American Urological Association on Monday, May 27 at 10:00 am Eastern Time. Dr. Marc Gittelman, Co-Director of Uro-Medix P.A./Uro-Care P.A. and Medical Director of South Florida Medical Research, will present the data in a poster entitled, "In-Clinic Evaluation of the Safety and Efficacy of Topical Alprostadil (PGE1) for the Treatment of Female Sexual Dysfunction." This is the first well-controlled Phase II in-clinic study to demonstrate that a topically applied medication can improve sexual arousal and satisfaction in post-menopausal women with FSAD. The study was a double-blind, placebo-controlled, crossover-design trial that evaluated patient responses to ALISTA administered in the clinic in conjunction with visual sexual stimulation. A total of 79 patients with a primary complaint of FSAD were treated at six investigational sites. VIVUS, Inc. is a 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. Current development programs target Female Sexual Dysfunction (FSD), Erectile Dysfunction (ED) and Premature Ejaculation (PE). 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 has partnered exclusively with Paladin Labs (TSE:PLB) to market and distribute MUSE.
This news release contains forward-looking statements about the potential commercialization of products in treating female sexual dysfunction and reflects management's current beliefs. However, as with any pharmaceutical under development, there are significant risks in development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive regulatory approval for any indication. Further, even if the Company were to receive regulatory approval for a product, there could be no assurance that such a product would prove to be commercially successful. Please see the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's Form 10-K and Forms 10-Q, which identify these and other risks and uncertainties that may cause actual results or events to differ materially from those described in this news release.
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CONTACT: VIVUS, Inc. Richard Walliser, 650/934-5200 ir@vivus.com www.vivus.com or Lippert/Heilshorn & Associates, Inc. (Investor Contacts) Bruce Voss / Jody Cain, 310/691-7100 bvoss@lhai.com / jcain@lhai.com or The Investor Relations Group (Media Contact) Lisa Lindberg, 212/825-3210 theproteam@aol.com |