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

To: VLAD who wrote (9074)	6/3/1998 10:47:00 PM
From: Frostman	Read Replies (2) \| Respond to of 23519

Vlad, here is the original(1/2/97) Vivus press release driven story regarding the New England Journal of Medicine study that is currently being trashed so badly. Frostman **************************************************************** New England Journal of Medicine Reports Clinical Results on New Treatment for Impotence -- MUSE -- Alprostadil Business Editors and Health Writers MENLO PARK, Calif.--(BUSINESS WIRE)--Jan. 2, 1997--According to a study published in today's issue of the New England Journal of Medicine, MUSE(R) (alprostadil) "was well-tolerated and effectively restored the capacity for erections and sexual intercourse in a substantial proportion of men with chronic erectile dysfunction." MUSE (alprostadil) is marketed by VIVUS, Inc. (NASDAQ: VVUS). "MUSE is a significant advancement in the treatment of erectile dysfunction," said Harin Padma-Nathan, M.D., assistant professor of urology at the University of Southern California School of Medicine and the lead author in the VIVUS clinical study. "This new treatment offers millions of men and their partners an effective and convenient treatment that can be easily integrated into a patient's sex life." The New England Journal of Medicine reported results from a VIVUS-sponsored multi-centered study of MUSE (alprostadil), the largest study ever published on men with organic erectile dysfunction. Nearly 1,000 men and their partners participated in the three-month home-treatment phase of the study. After in-clinic testing to find a suitable dose, 64.9 percent of the men treated with MUSE (alprostadil) reported sexual intercourse compared with 18.6 percent of the patients on placebo. The most common side effect was mild, transient penile pain which occurred in 10.8 percent of the administrations. "We're excited that new treatments, such as MUSE, are being developed to treat one of the most common male problems," said Thomas M. Bruckman, CEO of the American Foundation for Urologic Disease, a patient-based research, education and advocacy organization based in Baltimore. "From our surveys of patients who suffer from erectile dysfunction, we have found that they are looking for a safe, effective and convenient solution. This therapy offers patients another choice." MUSE (alprostadil) consists of a discreet, single-use, pre-filled, plastic applicator containing a micro-suppository of the drug alprostadil, a medication which increases penile blood flow. The stem of the applicator is inserted approximately one inch into the urethra where the medication is released, initiating an erection within 5 to 10 minutes which typically lasts 30 to 60 minutes. Transurethral therapy is a departure from existing therapies for erectile dysfunction and is based on the discovery that certain medications can be absorbed by the urethra and transported into the surrounding erectile tissues. "This was a landmark study in the field of erectile dysfunction because of the number of study sites, the number and diversity of patients, and the rigor of the clinical program," said Neil Gesundheit, M.D., vice president of clinical and regulatory affairs at VIVUS and the senior author of the article. "MUSE was broadly effective in men regardless of age or the cause of the problem. This new therapy should help many men who have been reluctant to seek treatment because of the more invasive nature of other options." Approximately 30 percent of men between the ages of 40 and 70 in the United States suffer from moderate to complete erectile dysfunction, a condition that increases in prevalence with age. The potential world figure is estimated to be 47 million men by the year 2000. MUSE (alprostadil) was cleared for marketing by the U.S. Food and Drug Administration in November 1996. Founded in 1991, VIVUS, Inc. is a leader in the development of advanced therapeutic systems for the treatment of erectile dysfunction. VIVUS has pioneered a novel therapy for erectile dysfunction known as the transurethral system for erection. This therapy consists of a proprietary, non-invasive, drug delivery system that delivers pharmacologic agents via the urethra. ***************************************************** I wonder what Neil Gesundheit, M.D., vice president of clinical and regulatory affairs at VIVUS (and the senior author of the article) thinks about the recent reports?