To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: MUSE, New Treatment For Impotence Cleared by the FDA URL: http://www.pslgroup.com/dg/E01A.htm Doctor's Guide November 20, 1996
MENLO PARK, Calif., Nov. 20, 1996 -- VIVUS, Inc. (Nasdaq: VVUS) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market MUSE(R) (alprostadil) urethral suppository for the treatment of erectile dysfunction, more commonly known as impotence. Leland F. Wilson, president and chief executive officer of VIVUS, said, "We are extremely pleased to now be able to market this innovative treatment. This first regulatory clearance is a major milestone for our company. MUSE (alprostadil) is the premier product in a series of products we plan to develop that will utilize our transurethral delivery technology." The company anticipates shipping product in early 1997. 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 incidence with age. The potential world market is estimated at 47 million men by the year 2000. "MUSE (alprostadil) offers new hope for men suffering from impotence," said Tom F. Lue, M.D., professor of urology, University of California, San Francisco. "This new treatment system is a significant advancement over current therapies. It is an effective treatment option that we can offer our patients." Current treatments consist of penile prostheic implants, vacuum devices, or needle injections of vasoactive substances into the penis, including alprostadil (prostaglandin E1), a medication which increases penile blood flow. MUSE (alprostadil) is a departure from existing therapies for erectile dysfunction, based on the discovery that certain medications can be absorbed by the urethra and transported into the surrounding erectile tissues. The product is a non-injectable, disposable plastic applicator containing a micro-suppository of the medication. The stem of the applicator is inserted approximately one inch into the urethra where the medication is released. The agent used in VIVUS' first product is alprostadil, a syntheic version of prostaglandin El, a naturally-occurring vasodilator cleared for marketing by the FDA for treating erectile dysfunction via needle injection in 1995 and prescibed for other uses since 1981. "MUSE (alprostadil) is clearly a very effective, desirable treatment choice," said J. Francois Eid, M.D., professor of urology, Cornell University School of Medicine. "It should be considered first-line therapy for all causes of erectile sysfunction. MUSE (alprostadil) offers men and their partners a convenient, discreet treatment that can be easily integrated into a patient's sex life." VIVUS conducted in the U.S. a large multi-center study of a treatment for organic erectile dysfunction with 996 men and their partners participating in a three-month home-treatment protocol. After individual titration, approximately 65 percent of men on active drug had intercourse at least once compared to 19 percent on placebo. Among those who responded to therapy, seven out of every ten treatments with MUSE (alprostadil) resulted in sexual intercourse. Treatment efficacy was shown in all causes of erectile dysfunction studied: vascular disease, diabetes, surgery or trauma, and other organic conditions. Quality-of-life data also were collected which indicated that patients treated with MUSE (alprostadil) experienced significant improvement in emotional well-being, and patient-couples improved their relationships with one another. The most common side effect, mild and transient penile pain, occurred in 11 percent of administrations. "This is a very significant advancement in the treatment of erectile sysfunction," said Thomas M. Bruckman, chief executive officer of the American Foundation for Urologic Disease, a patient research, education and advocacy organization based in Baltimore. "MUSE (alprostadil) offers hope for many patients. We believe the availability of MUSE (alprostadil) will encourage many more men suffering from erectile dysfunction to see a urologist for diagnosis and treatment." Patients seeking product information may call the MUSE Information Center at 1-888-367-MUSE (888 367-6873). Founded in 1991, VIVUS, Inc. is a leader in the development of advanced therapeutic systems for the treatment of 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. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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