NEW YORK (Reuters Health) - PNU-83757, a novel erectogenic potassium channel opener, is safe and well tolerated in men with erectile dysfunction (ED), researchers report in the June issue of The Journal of Urology.

Despite the availability of sildenafil, there are many men who continue to depend upon intracavernous therapy, lead author Dr. Ralph N. Vick and colleagues from the University of North Carolina, Chapel Hill, note.

In addition, although the currently available intracavernous therapies are effective, they are all associated with adverse side effects including priapism, fibrosis and postinjection pain, they add.

Dr. Vick's group randomly assigned 66 men who had erectile dysfunction to one of 11 PNU-83757 dose groups. Of the six men assigned to each group, five received PNU-83757 and one received placebo. Doses ranged from 0.25 µg to 140 µg.

Dr. Vick's team observed the first complete erection at a dose of 10 µg. Among the 25 patients receiving doses of PNU-83757 from 60 µg to 140 µg, only one man did not have an erectile response. Fifteen patients had partial erection and nine had complete erection, they note, and there were no serious adverse events or cardiovascular effects.

"PNU-83757 was efficacious and extremely well tolerated and the only adverse events were mild. Intracavernous PNU-83757 injections produce no postinjection pain in any patient," Dr. Vick and colleagues conclude.

They speculate that PNU-83757 may be superior to alprostadil for a select group of patients with postinjection pain and who have failed oral therapy..."but further investigation is required."

J Urology 2002;167:2618-2623.

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