Positive results from VIVUS' Phase 3 study of avanafil for ED in men with diabetes

VIVUS, Inc.Jun 7 2010

VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from the phase 3 REVIVE-Diabetes (TA-302) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED) in men with type 1 and type 2 diabetes. The REVIVE-Diabetes study met all three primary endpoints across the two doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. The study also demonstrated a favorable side effect profile and successful intercourse (as measured by SEP 3) in as little as 15 minutes and beyond six hours after dosing, without any restrictions for food or alcohol intake.

These results follow the avanafil data presentation at the American Urological Association (AUA) 2010 Annual Meeting last week, highlighting positive results from the company's first pivotal phase 3 study of avanafil evaluating treatment in men with a history of general ED.

Highlights of the REVIVE-Diabetes study include:

• More than 60% of subjects on the 200 mg dose of avanafil had erections sufficient for intercourse (SEP2) at the end of treatment.
• Patients treated with 100 mg and 200 mg of avanafil improved their ability to have successful intercourse three and four fold, respectively, from the start of treatment.
• Treatment with avanafil improved erectile function in a dose-dependent manner with significant increases in the IIEF scores from the beginning of treatment through the end of treatment.  Erectile function scores increased 41% and 45% for patients on the 100 mg and 200 mg doses, respectively, as compared to the placebo group with an increase of 17%.
• The most commonly reported side effects in patients taking avanafil included headache, nasopharyngitis, flushing, sinus congestion, sinusitis and dyspepsia. There were no drug-related serious adverse events in the study.

"More than half of all men living with diabetes face the challenges associated with chronic erectile dysfunction," stated Leland Wilson, chief executive officer of VIVUS. "This is the second phase 3 study in which avanafil demonstrated efficacy, fast onset-of-action and was well tolerated."

Diabetes is one of the most common causes of ED. 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. Diabetes can affect the ability to have erection in two ways: diabetic neuropathies can interfere with nerve impulses and cardiovascular circulation can be impaired by the disease.

"Men with diabetes and erectile dysfunction are historically difficult to treat because of the vascular and nerve challenges associated with their underlying disease," stated Laurence Belkoff, MD,  DO, FACOS, Chairman, Department of Specialty Surgeries and Division of Urology, Philadelphia College of Osteopathic Medicine, and a REVIVE-Diabetes study investigator. Avanafil's unique PK profile offers the potential for a highly selective therapy that is fast-acting and with a short plasma half-life. The efficacy, tolerability and onset within as little as 15 minutes seen with avanafil in this hard-to-treat population is encouraging for the millions of men living with diabetes and ED."