Vivus readies NDA as Ph3 trial hits goals for ED drug

Mountain View, CA-based Vivus ($VVUS) says that its experimental erectile dysfunction drug avanafil hit its goals in a Phase III study. And Vivus, which has been struggling to respond to the FDA's queries on its prospective obesity treatment Qnexa, says it's still on track to make its end-of-June deadline for filing for approval.

"Patients who have undergone a radical prostatectomy often have significant erectile dysfunction. Despite advancements in surgery, it can take several months or years to normalize erections. Radical prostatectomy patients are difficult to treat but the positive results of avanafil in these patients suggest that, if approved, avanafil could be an attractive treatment option," commented John Mulhall, M.D., an investigator in the study. "The trial met all the primary endpoints and detailed results of the study will be presented during the upcoming Cancer Survivorship Symposium to be held in Washington DC."

The study--TA-303--is the latest in a string of Phase III trials for avanafil. Vivus has already reported earlier successes and noted today that it didn't need this study to complete its NDA, but would go ahead and submit it with the rest of its data. The news helped buoy Vivus's shares this morning, which have been climbing steadily since it ran into a roadblock at the FDA.

- read the Vivus release
- see the Reuters story