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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: VLAD who wrote (11655)	7/16/1998 10:55:00 PM
From: Zebra 365	Read Replies (4) \| Respond to of 23519

VLAD, while I agree with your premise I have to penalize you for taking three extra zeros out of petty cash (check yer post). I only wish that we had one billion scripts behind us. <<After 1,000,000,000 scripts there was one guy who died after taking his 200th dose of MUSE. I doubt the MUSE actually killed him.>> HOWEVER....... New Study Demonstrates Long-Term Safety of VIVUS' MUSE; Data Presented Today at the American Urological Association MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 2, 1998--With the treatment of impotence becoming an everyday topic of discussion, talk is now turning to a key aspect of treatment -- safety. Data is being presented today at the American Urological Association (AUA) meeting in San Diego on a large clinical trial program of MUSE(R) (alprostadil), a treatment for erectile dysfunction manufactured and distributed by VIVUS, Inc. (NASDAQ:VVUS). Results released today of a large clinical trial program show that MUSE(R) (alprostadil) demonstrated long-term safety (in excess of 24 months) with regard to drug-related and/or serious adverse effects. MUSE was evaluated in 2,591 men with moderate to severe, organic erectile dysfunction in trials throughout the United States and Europe, and was shown to be well-tolerated with a favorable long-term safety profile. "This study confirms earlier findings that MUSE is a safe product," said Dr. Richard F. Labasky, lead investigator of the study and assistant professor of surgery at the University of Utah School of Medicine in Salt Lake City, Utah. "What's noteworthy is we've been able to follow patients who have been using MUSE for more than two years and the safety profile has remained very consistent. This study group included men after prostate surgery as well as those with severe vascular disease and diabetes, which highlights the safety of this drug in an organic dysfunction population." MUSE has been used by more than 600,000 men in the United States since January 1997. MUSE, the first and only transurethral delivery system for erectile dysfunction, is based on the discovery that the urethra can absorb certain medications. Because MUSE is administered locally, it minimizes potential systemic side-effects and drug:drug interactions. In placebo-controlled trials of MUSE, hypotension, dizziness and syncope occurred in 3%, 4% and 0.4%, respectively, of patients during in-clinic titration, and alprostadil-related side effects with home therapy included penile pain, occurring in approximately 30% of patients. Treatment with MUSE resulted in a minimal serious adverse event rate similar to treatment with placebo; MUSE did not increase the incidence of heart attack, stroke, hospitalization, disability or death. "Significant clinical experience has been gathered using MUSE," said Dr. Labasky. "The drug is well-tolerated and has a favorable long-term safety profile in patients with underlying organic conditions undergoing therapy for erectile dysfunction." In addition to the MUSE safety data released today at AUA, VIVUS is presenting abstracts on two investigational therapies for erectile dysfunction. One study discusses the efficacy of MUSE in conjunction with the ACTIS(R) adjustable penile constriction band. The study, which was led by Ronald W. Lewis, M.D., shows that the combination of MUSE and ACTIS "may augment the drug effect (of MUSE alone) and is an effective, non-invasive method to restore sexual function in the majority of men with erectile dysfunction." Another study focused on a new transurethral bi-mix, ALIBRA, consisting of transurethral alprostadil and the alpha blocker prazosin, shown in preliminary studies to be effective in men with erectile dysfunction. This study, which was led by Raymond A. Costabile, M.D., shows that the "combination of alprostadil/prazosin resulted in successful sexual intercourse in a significant number of men unresponsive to alprostadil alone." VIVUS is completing clinical studies in support of regulatory filings to obtain marketing clearance for ALIBRA, and the use of MUSE in combination with ACTIS. Founded in 1991, VIVUS, Inc. is a leader in the development of advanced therapeutic systems for the treatment of erectile dysfunction, commonly referred to as impotence. VIVUS has pioneered a novel therapy for erectile dysfunction known as MUSE(R) (alprostadil). This therapy consists of a proprietary, non-invasive drug delivery system that delivers pharmacologic agents via the urethra