Breaking News in Urology

The Newsweek magazine issue of November 17, 1997 featured "Impotency" as the cover story. In particular, three developmental-stage medications, each one a simple pill, were highlighted as having the potential to become "...the chemical cutting edge of the next sexual revolution." The three new drugs are briefly described below :

1. Viagra (sildenafil), Pfizer
This drug has completed clinical trials and was submitted to the FDA in September, 1997. Viagra is a Type V phosphodiesterase inhibitor. It is used as needed, an hour before intended sexual activity. According to Newsweek, this one offers "...the biggest hope...," having been tested in more than 4500 men and demonstrating an effectiveness of 45% - 81%. Viagra has received fast-track status by the FDA and may be approved as soon as mid-1998.

2. Vasomax (phentolamine), Zonagen
This drug has also completed clinical testing and has also been submitted to the FDA. Originally, this drug was given as injection therapy for impotency, and it has now been re-formulated into an oral preparation. Like Viagra, Vasomax causes corporal smooth muscle relaxation and penile erection; it is also taken as needed prior to intended sexual activity. Vasomax could also be approved during 1998.

3. Spontane (apomorphine), TAP Pharmaceuticals, Inc.
Appearing to act centrally upon neural mechanisms for erections, Spontane is still in clinical trials. It promises to act best in men with psychogenic impotency, and generally in response to physical stimulation.

USRF has from the onset been a study site for the U.S. clinical trials for Viagra. A number of our patients are currently in long-term open-label extensions of the early Viagra studies, and for the most part, our patients attest to the drug's safety and efficacy. At the present time (4th quarter, 1997), no new patients are being accepted into studies, pending FDA action.

*Note: At the time of this writing, Newsweek did not have a website. Reprints of the cover story, "The New Science of Impotence: Can It Be Cured with a Pill?," are available by phone at 1-212-445-4870.



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