Vivus announces five positive studies on avanafil presented to Sexual Medicine Society

New York, Nov. 17 - Vivus, Inc. said five abstracts reporting positive results from phase 2 trials of its avanafil treatment for erectile dysfunction were presented at the annual meeting of the Sexual Medicine Society of North America in New York.

"Taken together, these studies demonstrate the specificity, rapid onset of action, efficacy and safety of avanafil and indicate the potential of the drug to become an exciting new treatment for ED [erectile dysfunction], well-matched to the needs of patients and a market that is currently seeking new options and approaches," said John Dietrich, vice president of Research and development of Vivus, in a news release. "We look forward to continuing the development of avanafil and will be working closely with the FDA in the coming months to formulate our phase 3 clinical program."

In one study, Avanafil demonstrated the greatest selectivity for the enzyme PDE5, which is the enzyme involved with facilitation of erections, when compared to sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis), the currently approved oral treatments for erectile dysfunction, Vivus said.

Researchers also found that avanafil is rapidly absorbed after oral administration, with maximum concentrations in the blood stream occurring approximately 35 minutes after dosing. The compound also demonstrated a fast disappearance from blood, having a short plasma half-life of less than 1.5 hours. These properties may make avanafil well-suited as a treatment for erectile dysfunction.

In an animal model, avanafil had no impact on various tests involving vision. Certain adverse ocular effects have been seen in patients taking the approved erectile dysfunction medications.

In a clinical study, combined treatment with avanafil plus nitroglycerin resulted in smaller changes in blood pressure and heart rate, a shorter duration of interaction with nitroglycerin, and fewer subjects with clinically significant hypotension than did combined treatment with sildenafil and nitroglycerin. This finding suggests avanafil may be a safer PDE5 inhibitor for patients who are at risk for using nitroglycerin, although results will have to be confirmed in future trials.

In a phase 2 study that involved more than 280 men with mild-to-moderate erectile dysfunction, avanafil produced dose-related, highly significant increases in various aspects of penile function, including the ability to successfully complete intercourse. Patients were instructed to only wait 30 minutes to initiate sexual activity. In this study the drug was safe and well-tolerated by the participants.

Vivus is a Mountain View, Calif., company working on products to restore sexual function for women and men.

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