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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Barron Von Hymen who wrote (182)	6/3/1998 11:25:00 AM
From: Anthony Wong	Respond to of 1722

Vivus Inc.'s Muse Shows Disappointing Results in Clinical Use Bloomberg News June 2, 1998, 10:31 p.m. PT Vivus Inc.'s Muse Shows Disappointing Results in Clinical Use San Diego, June 2 (Bloomberg) -- Physicians prescribing Vivus Inc.'s Muse, an impotence treatment that's injected into the penis, found the drug less effective than reported in prior clinical trials, new research shows. A study of some 115 men suffering from impotence found that only 27 percent treated with Muse were able to obtain an erection they deemed sufficient for intercourse. That's compared to a response rate of 60 to 70 percent reported in a company-sponsored study of about 1,500 men described in a 1997 New England Journal of Medicine article. The newer study ''represents what actually happens in an urban urology practice when unselected patients come into a urologist's office,'' said Pat Fulgham, a Presbyterian Hospital physician who presented the results at the annual meeting of the American Urological Association in San Diego. The data comes at a tough time for Vivus, which has seen Muse prescriptions plunge since the April introduction of Pfizer Inc.'s Viagra, an impotence pill that's more attractive to patients because it's much easier to administer than Muse. The Mountain View, California-based company reported a wider-than- expected loss of $2.4 million in the first quarter as it boosted its sales force in a bid to talk up its main product Muse before Pfizer introduced Viagra in what turned out to be one of the most successful new-drug launches to date. The men in Fulgham's study group reported more severe side effects than those in the company-sponsored trial, with some 40 percent of patients reporting penile pain or burning sensations and only 18 percent choosing to continue using the drug at the end of the trial. Vivus Chief Executive and President Leland Wilson said the differences in the two studies could be accounted for by the fact that the men treated in the earlier trials received careful instruction in how to use the Muse system to inject alprostadil pellets into their penis through the urethra. ''The reality is that efficacy varies from site to site. It's almost always related to the time and attention that doctors give their patients,'' Wilson said in an interview. ''Nobody has ever delivered a product through trans-urethral injection before.'' Viagra has emerged as the dominant first-line treatment for impotence, relegating Muse to the position of being a second-line alternative along with injections like Pharmacia & Upjohn Inc.'s Caverject. Still, with some 1.5 million men already using Viagra, analysts and physicians say the secondary-treatment market could be bigger than it was before Viagra's introduction, assuming that 20 to 30 percent of patients who don't respond to Viagra seek other treatments. Vivus has issued statements recently pointing out that Muse can be used by patients being treated with nitrates -- a heart medication that can be dangerous when combined with Viagra. In placebo controlled studies of Muse of some 2,591 men, the company-sponsored trial found that 30 percent of patients reported side effects including penile pain while using the drug at home. The trial also found that while the drug was being administered in the doctor's office to determine dosage, some 3 percent of patients experienced hypotension, or a decrease in blood pressure to below-normal levels, while 4 percent became dizzy and 0.4 percent lost consciousness. ''The drug is well tolerated and has a favorable long-term safety profile in patients with underlying organic conditions undergoing therapy for erectile dysfunction,'' said Richard Labasky, a University of Utah School of Medicine researcher who was lead investigator in the study. --Jim Finkle in San Diego through the San Francisco newsroom 609-