FEATURE/Hope for Women with Female Sexual Arousal Disorder.Feature Editors/Business Editors/Health/Medical Writers FEATURE...Women's Health & Wellness MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--July 2, 2003 VIVUS, Inc. (Nasdaq NM: VVUS) Long thought to be purely psychological, it is now believed that Sexual Arousal Disorder Sexual arousal disorder The inhibition of the general arousal aspect of sexual response. Mentioned in: Sexual Dysfunction in women may result from physical or organic causes such as pregnancy, natural childbirth, caesarian caesarian n. Variant of cesarean. birth, hysterectomy or other organic physical causes. ALISTA(TM), a proprietary formulation of alprostadil, applied topically to the female genitalia genitalia /gen·i·ta·lia/ (jen?i-tal´e-ah) [L.] the reproductive organs. ambiguous genitalia , for the treatment of Female Sexual Arousal Disorder Female Sexual Arousal Disorder Definition Female sexual arousal disorder (FSAD) occurs when a woman is continually unable to attain or maintain arousal and lubrication during intercourse, is unable to reach orgasm, or has no desire for sexual , was found in recent trials to improve the level of sexual satisfaction of postmenopausal post·men·o·paus·al adj. Of or occurring in the time following menopause. postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr women. VIVUS, Inc., a pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, recently reported the results from its Phase II at-home dose-ranging study of ALISTA. Researchers found that women who received the 400-microgram dose of ALISTA experienced a statistically significant improvement (p less than 0.017) in their level of satisfactory sexual arousal and/or orgasm. The double-blind, placebo-controlled trial included approximately 230 women who received treatment for a period of two months with ALISTA at doses ranging from 200 to 800 micrograms or placebo. The study results were based on the percentage of sexual encounters that resulted in satisfactory sexual arousal and/or orgasm, as recorded in daily patient diaries. The 400-microgram dose was the same dose associated with a statistically significant increase in the overall sexual response in an in-clinic study completed by VIVUS in 2002. "Right now, current treatment options for female sexual dysfunction are limited," commented Dr. Marc Gittelman, Director of the Miami Center for Sexual Health. "The new ALISTA results may offer hope for patients who experience a physical or organic component to their sexual problems." ALISTA's active ingredient, alprostadil, is a synthetic version of prostaglandin E1 (PGE PGE Pacific Gas and Electric Company PGE Portland General Electric PGE Prostaglandin E PGE Platinum Group Elements PGE Pacific Great Eastern (Railroad) PGE Phenyl Glycidyl Ether PGE Perfect Girl Evolution 1), 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 (ED). ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement engorgement /en·gorge·ment/ (en-gorj´ment) 1. local congestion; distention with fluids. 2. hyperemia. engorgement distention. and other natural processes that occur during sexual stimulation. Clinical studies have demonstrated that ALISTA is well tolerated both locally and systemically. 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 FSD Female Sexual Dysfunction FSD File System Driver FSD Family Support Division FSD Fire Services Department (Hong Kong) FSD Full Scale Development FSD Full Scale Deflection FSD Federal Systems Division ), 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 Meda AB (Stockholm: MEDAa.ST) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Paladin archetypal gunman who leaves a calling card. [TV: Have Gun, Will Travel in Terrace, I, 341] See : Wild West Labs (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). : PLB (Picture Level Benchmark) A benchmark for measuring graphics performance on workstations. The Benchmark Interface Format (BIF) defines the format, the Benchmark Timing Methodology (BTM) performs the test, and the Benchmark Reporting Format (BRF) generates results in ) 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 future clinical studies will confirm the preliminary results discussed in this news release or 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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