Biopharmaceutical company VIVUS has initiated an open label safety study of the investigational drug avanafil in males with erectile dysfunction. The Mountain View, Calif.-based company also announced that it has completed enrollment in REVIVE, the first of several planned Phase 3 studies of avanafil. Approximately 650 patients have been enrolled in the randomized, double-blind, placebo-controlled study. Results are expected in the fourth quarter of 2009.
VIVUS previously made news with their obesity drug Qnexa, which is a combination of the appetite supressant phentermine and the main ingredient in Johnson & Johnson‘s epilepsy drug Topamax. Data from two studies of Qnexa will be presented later this month at the American Diabetes Association’s annual meeting. Like avanafil, Qnexa is in Phase 3 clinical trials.
Avanafil is a PDE5 inhibitor similar to Viagra and Cialis. According to the company website, avanafil starts working within 15 to 20 minutes of administration and appears to be associated with less hypotension than Viagra. The Massachusetts Male Aging Study estimates that erectile dysfunction effects 52 percent of men between the ages of 40 and 70. Some companies that are developing products to treat ED are FS Physiomed, Cellegy Pharmaceuticals, Encore, Harvard Scientific Corp., and Schwarz Pharma.