phase III
VIVUS Initiates Second Pivotal Phase 3 Trial of Avanafil for Treatment of Erectile Dysfunction
REVIVE-Diabetes (TA-302) Study to Evaluate Avanafil for Treatment of Erectile Dysfunction (ED) in Men with Diabetes, One of the Most Common Causes of Erectile Dysfunction
VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated a second pivotal Phase 3 study of avanafil, its investigational new drug for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor.
The study, REVIVE-Diabetes (TA-302), is a multicenter, randomized, double-blind, placebo-controlled trial and will evaluate the safety and efficacy of avanafil in the treatment of 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. The co-primary endpoints of the study will be improvement in erectile function as measured by changes in the sexual encounter profile (SEP) questions 2 and 3, 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 3 development program.
“There has not been a new treatment option for men with ED in more than five years,” stated Andrew McCullough, MD, associate professor of clinical urology, NYU School of Medicine and REVIVE-Diabetes clinical investigator. Early data suggest that avanafil may provide a fast-acting therapy with a short half-life, which, if approved, may represent a noteworthy advance for the millions of men living with ED and searching for new options.”
Diabetes is one of the most common causes of ED; clinical data suggest that at least 50 percent of diabetic men will experience difficulties with erectile function. Men with diabetes are up to three times more likely to have ED than non-diabetic men and appear to experience it earlier in life. The significance of ED increases with the severity and duration of diabetes as well as with advanced age.
“Evidence suggests that there is room for significant improvement in the current treatment of ED,” Charles Bowden, MD, senior director, clinical development for VIVUS. “We’re pleased with the promising results demonstrated thus far with avanafil, and with the momentum behind our Phase 3 program. Enrollment in our first pivotal study, REVIVE, initiated in December to evaluate avanafil in ED, is ongoing. REVIVE-Diabetes will be conducted at many of the same sites as REVIVE.”
It is expected that this study will enroll approximately 375 patients at about 30 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. REVIVE-Diabetes will study two doses of avanafil. More information about the trial can be found at
http://www.clinicaltrials.gov.
As previously disclosed, VIVUS has entered into a $30 million funding collaboration with Deerfield Management to fund the Phase 3 program.
thought about getting in at 4.50 but opted not to...of course...big volume day today too
Whatever.
