(RTTNews) -  Wednesday, biopharmaceutical company VIVUS Inc. (VVUS: News ) announced positive results from Revive or TA-301, a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug for the treatment of erectile dysfunction or male impotence which is a sexual dysfunction characterized by the inability to develop or maintain an erection of the penis. Erectile dysfunction affects an estimated 18 million men in the U.S. alone.

The company noted that the Revive study met all primary endpoints across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile or SEP and improvements in the International Index of Erectile Function or IIEF score, the company said.

The pivotal study also demonstrated successful intercourse in 30 minutes or less, and a favorable side-effect and safety profile.

The company said that Nearly 80% of sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse, Avanafil was well tolerated as demonstrated by a high retention rate (85%), there were no drug-related serious adverse events in the study, Avanafil patients had low reports of common PDE5i side effects.

The most commonly reported side effects in patients taking avanafil (all doses combined) included headache, flushing, and nasal congestion, there were no reports of visual disturbances such as "blue vision."

Revive is the first of four phase 3 avanafil trials. Additional phase 3 studies include treatment in diabetic males with ED and in males with ED following a post-radical prostatectomy, each with a treatment period of approximately 16 weeks. The company noted that it look forward to further advancing the clinical program toward filing an NDA for avanafil in late 2010 or early 2011.
Leland Wilson, chief executive officer of Vivus said, "Erectile dysfunction is a significant problem among more than half of all men over the age of 40. While sales of currently available ED therapies exceed $3.8 billion a year, persistent switching by patients suggests that patients are less than satisfied with current therapies."

LeRoy Jones, Clinical Associate Professor, Urology, University of Texas Health Science Center, said, "Another important consideration of patients is how quickly their ED therapy works; these data suggesting that avanafil achieves a full effect in 30 minutes or less, with a window of opportunity for intercourse extending beyond six hours, would be a welcome option for ED treatment."

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