VIVUS Initiates Avanafil Phase 3 Trials in Males with ED
News Dec 15, 2008
VIVUS, Inc. has announced it has initiated the first of several pivotal phase 3 studies of avanafil, an investigational product for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor.
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 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 (IIEF).
“Initiation of the phase 3 studies of avanafil is an important corporate milestone for VIVUS,” stated Leland Wilson, president and chief executive officer of VIVUS. “The sales of PDE5 inhibitors world wide exceeded $3 billion in 2007. We believe that avanafil has distinct potential advantages as compared with approved ED therapies. Our investigational data from phase 2 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.”
The phase 3 study will be conducted following discussion and agreement with the Food and Drug Administration 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 United States.