Avanafil is a next-generation, highly selective oral phosphodiesterase type 5 (PDE5) inhibitor therapy being investigated for the treatment of ED. Studies to date have demonstrated that avanafil has a fast onset of action, with activity apparent in 15 minutes or less after administration.

Vivus Inc. said a late-stage trial of its erectile-dysfunction treatment had a surprisingly high magnitude of success in the first 15 minutes after taking the drug. VIVUS,Inc. (Nasdaq: VVUS) today announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED).

Patients who attempted intercourse within 15 minutes of dosing were successful 67%, 69% and 72% of the time on 50, 100 and 200 mg of avanafil, respectively, as compared to 29% of the patients on placebo (p<0.05). Vivus had already reported that its avanafil drug appeared to have fewer side effects than other treatments.

“The magnitude of success in the first 15 minutes was surprising,” Chief Executive Leland Wilson said Monday. “This new data further strengthens the profile and differentiation of avanafil from other currently available oral ED therapies.” He said patients and physicians have told the company that rapid onset is an important attribute when selecting a therapy for erectile dysfunction.

“From our discussions with patients and physicians, we knew that rapid onset was an important attribute in the selection of an ED therapy. A recent study in 1,900 patients with ED showed that 75% of patients identified rapid effect as an important treatment expectation. Knowing that avanafil can be effective within 15 minutes should create an attractive position in the PDE5 market,” stated Charles Bowden, M.D., Senior Director, Clinical Development at VIVUS.

In November, Vivus said avanafil was found safe and effective, putting the company on course to file a new-drug application with the U.S. Food and Drug Administration by early 2011.

About Study:

REVIVE (TA-301) was a randomized, double-blind, placebo-controlled phase 3 study of avanafil in 646 men with a history of generalized ED for at least six months; 72% of study participants had tried at least one other ED treatment. Patients underwent a four-week, non-treatment run-in period followed by 12 weeks of treatment with one of three doses of avanafil: 50mg, 100 mg and 200mg, or placebo.

Patients were instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. The primary endpoints of the study were improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF Domain of the International Index of Erectile Function (IIEF) score; secondary endpoints included patient satisfaction with erections and with sexual experience.

REVIVE is the first of four phase 3 avanafil trials. Additional phase 3 studies include treatment in diabetic males with ED (REVIVE-Diabetes, TA-302) and in males with ED following a radical prostatectomy (TA-303), each with a treatment period of approximately 16 weeks. In March 2009, VIVUS initiated an open-label safety study (TA-314) evaluating the long-term safety and tolerability of avanafil as part of its path toward NDA filing.

TA-314 is being conducted over one year in approximately 600 patients across 40 U.S. centers; patients completing either the 16-week REVIVE or REVIVE-Diabetes studies are eligible to participate in TA-314. Results of the study are expected to be available by late-2010. In total, the phase 3 avanafil clinical program will enroll approximately 1,300 patients.

Read more in detail: http://ir.vivus.com/releasedetail.cfm?ReleaseID=436583