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Vivus says erectile dysfunction drug meets goals 2010-06-07
By Associated Press

MOUNTAIN VIEW, Calif. -Vivus Inc. said Monday its potential erectile dysfunction drug for men with diabetes met key goals in a late-stage study.

The company said avanafil, in two separate doses, improved erectile function in the 390-person study that involved men with type 1 or type 2 diabetes who also had erectile dysfunction. On average patients had ED for at least six years and had diabetes for over 11 years.

Vivus said more than 60 percent of men on a 200-milligram dose of avanafil had erections sufficient for intercourse at the end of treatment. Erectile function scores increased 41 percent and 45 percent for patients on the 100 mg and 200 mg doses, respectively, compared with 17 percent improvement in the placebo group.

The study demonstrated successful intercourse in as little as 15 minutes and beyond six hours after dosing, without any restrictions for food or alcohol intake, Vivus said.

"This is the second phase 3 study in which avanafil demonstrated efficacy, fast onset-of-action and was well tolerated," Vivus CEO Leland Wilson said in a statement. The Revive-Diabetes study is one of four late-stage avanafil trials. In total, the phase 3 program will enroll approximately 1,300 patients.

Side effects in the study included headache, flushing and sinus congestion.


 


 
 
 
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