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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: R. K. (Chip) Constantian Jr. who wrote (3141)6/3/1998 2:24:00 AM
From: steve wong  Read Replies (1) | Respond to of 9523
 
TO ALL: Even Better Bedtime Story! MUSE ineffective!

Tuesday June 2, 8:28 pm Eastern Time

Vivus impotence drug is ineffective in many - report

By Mark Egan

LOS ANGELES, June 2 (Reuters) - Vivus Inc.'s impotence drug MUSE is ineffective in most men when taken in a clinic and
even less useful for those taking it at home, despite a 1997 study that showed it worked in most patients, researchers said on
Tuesday.

''For a variety of possible reasons efficacy in a controlled clinical trial has not translated into clinical usefulness of the MUSE
system for the majority of our patients suffering from erectile dysfunction,'' Dr. Pat Fulgham wrote in a presentation made at the
American Urological Association's annual meeting in San Diego.

Fulgham, of the Presbyterian Hospital in Dallas, told reporters on a conference call that only 27 percent of patients in his study
achieved sufficient erections for sexual intercourse despite higher doses.

Vivus officials did not return calls for comment.

Impotence is the persistent inability to achieve or maintain an erection sufficient for sexual performance and affects more than
30 million men in the United States.

The trial of 115 male patients, aged 65 on average, who suffered from impotence was begun after doctors found that the
reported efficacy of MUSE was not translating into effective treatment in patients taking the drug in their clinics.

Since the doctors were disappointed with the results they were getting in their patients they undertook a study designed to
mimic the New England Journal of Medicine report on the drug which showed it to be effective in most patients.

That 1997 study of MUSE, an acronym for medicated urethral system for erection, said that 65.9 percent of men administered
MUSE in the clinic achieved an erection sufficient for intercourse. It further said that 64.9 percent of men who took MUSE at
home had intercourse at least once.

Patients in Fulgham's trial were administered MUSE in the clinic and only 27 percent gained an erection sufficient for
intercourse, he said. Follow-up revealed that only 18.6 percent of the patients continued using the treatment at home.

Fulgham said difficulty in using the MUSE system in the absence of a medical professional may have contributed to the drop
off in those using the treatment at home.

MUSE is a dose of the drug alprostadil in the form of a pellet. Patients insert a plastic applicator into the tip of their penis
dispensing the pellet. An erection should develop within 10 minutes and last for 30 to 60 minutes.

Earlier Vivus said a separate MUSE presentation made at the conference showed the treatment to be safe in patients with
severe erectile dysfunction.

Menlo Park, Calif.-based Vivus has been fighting to convince the public that its MUSE is better than Pfizer Inc.'s much hyped
drug Viagra, the first oral pill for impotence.

Vivus has maintained that its treatment is more effective in men with severe impotence than Viagra. But another report at the
San Diego meeting on Tuesday claimed Viagra was effective in half of men with the most severe impotence problems which
suggests Viagra could further erode Vivus' market.

Since its launch in April more than 1.5 million prescriptions for Viagra have been written making it one of the most popular
drugs ever in the United States.