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news.Vivus, a biopharmaceutical company, has initiated a second pivotal Phase III study of avanafil, its investigational new drug for the treatment of erectile dysfunction. It is expected that this study will enroll approximately 375 patients at about 30 sites in the US.
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The study, Revive-diabetes, is a multicenter, randomized, double-blind, placebo-controlled trial and will evaluate the safety and efficacy of avanafil in the treatment of erectile dysfunction (ED) in men with type 1 or type 2 diabetes.
Subjects who meet the inclusion criteria will undergo a four-week non-treatment run-in period followed by 12 weeks of treatment. Revive-diabetes will study two doses of avanafil.
The co-primary endpoints of the study will be improvement in erectile function as measured by changes in the sexual encounter profile (SEP) questions two and three, and improvement in erectile function as measured by the erectile function domain score of the International Index of Erectile Function (IIEF).
The SEP is a self-administered patient diary and the IIEF is a patient questionnaire; both are used as standard diagnostic tools to assess erectile dysfunction. Revive-diabetes is the second of three planned pivotal studies in the avanafil Phase III development program.
Charles Bowden, senior director, clinical development for Vivus, said: “We are pleased with the promising results demonstrated thus far with avanafil, and with the momentum behind our Phase III program. Enrollment in our first pivotal study, Revive, initiated in December 2008 to evaluate avanafil in ED, is ongoing. Revive-diabetes will be conducted at many of the same sites as Revive.”