New erectile drug lasts longer than Viagra, companies say as study is released

Monday, May 27th 2002, 12:00 am

By: News On 6

INDIANAPOLIS (AP) _ A yet-to-be-approved impotence drug developed by Eli Lilly and Co. and Icos Corp. appears to be longer-lasting than Viagra, the companies said, citing a study being released at a medical conference.

Patients in the study reported success in achieving erections lasting from 24 hours to as long as 36 hours after taking a 20-milligram pill of Cialis, said Indianapolis-based Lilly and Bothell, Wash.-based Icos on Saturday.

The study did not compare Cialis' effects directly with those of Viagra, the $1.2 billion-a-year drug for erectile dysfunction that Pfizer Inc. introduced in 1998.

``There are other studies that have looked at the length of the duration of Viagra's effects, and usually it's in the eight-to-12 hour range maximum,'' Dr. Raymond Rosen, the author of the Cialis study, said in a phone interview.

Results of the peer-reviewed, final-phase study were to be released on Monday at the American Urological Association conference in Orlando, Fla.

The study, funded by Lilly and Icos, involved 348 men with mild to severe erectile dysfunction who were given either a placebo or Cialis over eight weeks.

Patients were asked to attempt intercourse with their partners on two occasions 24 hours after taking a dose, and on two occasions after 36 hours.

About 59 percent of the patients reported positive effects in their ability to have sex after 36 hours.

Cialis (pronounced see-ALL-iss) ``showed a consistent effect at both time points,'' said Rosen, a human sexuality researcher at the University of Medicine and Dentistry of New Jersey and a psychologist. ``Also, in this study, the duration of effectiveness did not appear to influence the incidence or severity or side effects.''

The most commonly reported side effects include headaches and upset stomachs, with less than 2 percent of patients dropping out of the study because of side effects.

Dr. Gerald Brock, an associate professor of urology at the University of West Ontario, said the findings that Cialis' effects are longer-lasting than Viagra's are significant because many patients report that the window during which Viagra is effective hinders their sex life.

``With Cialis, the vast majority of the men, even at 36 hours, are still going to have sexual function,'' said Brock, who was not involved in the Cialis study. ``I think that dramatically results in an improvement in spontaneity for couples to have sex on their own time schedule.''

Rosen attributes Cialis' longer-term effects to a difference in the rate at which it is chemically active in the bloodstream and eliminated from the body compared with Viagra.

The drugs work in a similar fashion by targeting the same enzyme that can increase blood flow to the penis. But they have different molecular structures, Rosen said.

Lilly and Icos developed Cialis in a joint venture. The companies had hoped to win marketing approval this year. But that has been pushed back to next year after the Food and Drug Administration last month said it would require additional studies before deciding on approval.

The companies have said they expect Cialis' label will warn against use by some patients with heart problems.

Pfizer officials could not be reached for comment Saturday on the Cialis findings.

However, Pfizer spokesman Geoff Cook said in March that the company expects the emergence of competing erectile dysfunction drugs will only boost its fortunes.

``We strongly believe the competition is going to grow the market,'' Cook said. ``This condition still has a stigma attached to it.

Bayer Corp. also is awaiting FDA approval for another impotence treatment, vardenafil.