VIVUS, Inc. , a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated the first of several pivotal phase 3 studies of avanafil, our investigation product for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigation 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."
"Previous studies of avanafil have shown very promising results, both in terms of efficacy and safety, for the treatment of ED," commented Dr. Charles Bowden, director of clinical development at VIVUS. "We are now beginning the final phase of clinical development of avanafil with REVIVE (TA-301), the first of four planned phase 3 trials. Additional phase 3 studies will include treatment in diabetic males with ED and in males with ED following a post-radical prostatectomy, each about 16 weeks in duration. We also plan to initiate a 12-month safety study in the first half of 2009. In total, the pivotal phase 3 studies should enroll over1,200 subjects."
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. 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, 100 mg and 200mg.(health drugs).