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Apomorphine Produces Rapid Erections in Men With Erectile Dysfunction: Presented at AUA

By Jill Stein

CHICAGO, IL -- April 30, 2003 -- New data indicate that apomorphine hydrochloride tablets administered sublingually (SL) at doses of 2 and 3 mg result in a rapid onset of erections in men with erectile dysfunction.

The data, reported here April 29^th at the 98^th Annual Meeting of the American Urological Association, are from a meta-analysis of 4 similarly designed multicenter, European and North American placebo-controlled, crossover trials.

Dr. Dimitrios Hatzichristou, from Aristotle University, in Thessaloniki, Greece, presented the findings.

The multi-analysis included 554 men with a mean age of 55 years who received the recommended doses of apomorphine SL (2 and 3 mg). They were asked to record the time to erection after placing the study drug under the tongue. Partners were also asked to keep diaries to record patients' responses.

Patients presented with a range of erectile dysfunction severities. Twenty-nine percent had severe erectile dysfunction.

Results showed that the median time to erection with the 2 mg dose was 17.5 minutes and 18.8 minutes with the 3 mg dose.

Overall, 33.8% of erections achieved at these doses occurred within the first 10 minutes, giving a cumulative total of 71% of erections occurring within 20 minutes of administration (P=0.001),

The investigators also analyzed the time to erection with apomorphine SL by age group. Overall, 75.3% of men 45 years of age or younger had erections within 20 minutes of administration, 69.9% in men aged between 46 and 55 years, 72.4% in those aged 56 to 65 years, and 61.6% for those older than 65 years.

"Thus, there were no significant differences in the time to erection after apomorphine SL administration when patients were stratified by age," Dr. Hatzichristou said.

"Only about 10% to 25% of men who have erectile dysfunction present for treatment, and concern about present treatments and side effects is often responsible," said Dr. John P. Mulhall, director of the Sexual Medicine Program and Sexual Medicine Research Laboratory at Weill Medical College of Cornell University and New York-Presbyterian Hospital in New York, who did not participate in the study. "We're hoping that with the development of new drugs and new classes of drugs, more patients will seek treatment."

There are many causes for patient concern, he added. "People say they are worried about side effects like the headache, flushing, nasal congestion, and blurred vision associated with the PD5 inhibitors," he said. "Others don't like treatments that involve needles or inserting suppositories into their penis," he added. "Some people can't take some medications because of certain medical conditions."

Dr. Mulhall added that difficult administration and integration into sexual relations are additional important limitations of present therapies. "For example, the PD5 inhibitors are supposed to be taken on an empty stomach and sexual activity is not supposed to start until an hour after that. So, for this reason there is a value to introducing not just new drugs but new classes."

At present, apomorphine SL, which is part of a new class called centrally acting agents, is approved for use in several countries outside the United States. With apomorphine SL, apomorphine is rapidly absorbed from the buccal mucosa and reaches detectable plasma concentrations within 10 minutes of placing the tablet under the tongue.

The study was funded by TAP Pharmaceutical Products.


[Study title: Time to Erection With Apomorphine Sublingual 2 and 3 mg in Men With Erectile Dysfunction. Abstract 1407]

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