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The US Food and Drug Administration (FDA) will soon review for approval two new experimental drugs that are safer than Viagra (sildenafil) and have better drug-drug interaction profiles, according to Ronald Lewis, MD, of the Urology Department at the Medical College of Georgia. The two drugs potentially offer good news for HIV patients with erectile dysfunction. Potent anti-HIV combination drug therapy can induce erectile dysfunction in HIV patients. In addition, HIV patients taking both Viagra and a protease inhibitor, especially Norvir (ritonavir) are at risk for experiencing enhanced adverse side effects due to Viagra.

Penile erection can be stimulated through different pathways, and researchers have identified different types of erectile dysfunction and different pharmacologic approaches to treat them. Lewis spoke about two new experimental drugs, Vasomax and Uprima, at the American Urological Association annual meeting in Dallas. Lewis said these new agents would make combination therapy for erectile dysfunction a possibility. In addition, with three drugs to choose from, physicians will be in a better position to recommend the most effective drug for each patient based on each drug's mechanism of action and the specific cause (when known) of erectile dysfunction in the individual patient.

Vasomax (phentolamine), manufactured by Schering Plough, is an oral drug that enhances blood flow to the penis. An alpha adrenergic receptor blocker (leading to blood vessel dilation) previously available only as an injectable drug, Vasomax produces maximum effects within 30 to 60 minutes. Fewer than ten percent of men in the Phase III studies of Vasomax reported adverse side effects, which include headache, flushing and congestion.

Uprima (apomorphine though not an opiate narcotic) manufactured by TAP Holdings, Inc., is taken sublingually (under the tongue), a route of administration that could confer a significant treatment advantage because the drug's effects will be experienced very quickly, within 15 to 25 minutes, according to Lewis. Uprima works as an amplifier of the central nervous system (CNS). The drug produces erectile signaling in the brain as well as enhancing blood flow to the penis. Uprima does not cause mood changes and is effective for erectile dysfunction due to both psychological and organic causes, according to Lewis. An important advantage of Uprima is that individuals taking antihypertensive medications can use it safely, said Lewis, who was a co-investigator of Phase III trials of the drug.

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