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news.US-based pharmaceutical company Vivus has initiated the first of several pivotal Phase III studies of avanafil, an investigational product for the treatment of erectile dysfunction.
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The first study, Revive (TA-301), is a randomized, double-blind, placebo-controlled, efficacy and safety study of avanafil in men with a history of erectile dysfunction (ED). Subjects will undergo a four-week run-in period followed by 12 weeks of treatment. Subjects will be randomized to placebo or one of three dose levels of active drug.
The primary endpoints of the study will be improvement in erectile function as measured by the sexual encounter profile and improvements in the international index of erectile function score.
The Phase III study will be conducted following discussion and agreement with the FDA including a special protocol assessment of Revive (TA-301). It is expected that TA-301 will enroll over 600 patients at approximately 40 sites in the US. Subjects are instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. TA-301 will study three doses of avanafil: 50mg, 100mg and 200mg.
As previously announced, Vivus has entered into a $30 million funding collaboration with Deerfield Management for the funding of Phase III.
Leland Wilson, president and CEO of Vivus, said: Initiation of the Phase III studies of avanafil is an important corporate milestone for Vivus. We believe that avanafil has distinct potential advantages as compared with approved ED therapies.
Our investigational data from Phase II studies indicates a shorter time to onset and a shorter half-life, which we will investigate further to demonstrate potential safety advantages. Top-line results from the first study could be available by the end of 2009.