MUSE Impotence drug ineffective,
researchers say
Copyright c 1998 Nando.net
Copyright c 1998 Reuters News Service
LOS ANGELES (June 3, 1998 01:20 a.m. EDT nando.net) - 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, researchers said 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," Pat Fulgham, a doctor, 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.
By MARK EGAN, Reuters News Service |
