VIVUS Reports Study Results Demonstrating STENDRA Effective for Sexual Activity within 15 Mins in Men with ED

VIVUS, Inc.

today announced positive results from a multicenter, placebo-controlled study, TA-501, designed to assess the efficacy of STENDRA™ (avanafil) in approximately 15 minutes. In the study, STENDRA patients achieved statistically significant improvement over placebo, in the mean proportion of attempts that resulted in erections sufficient for successful intercourse, as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose after being taken. The market opportunity for ED medical treatments continues to grow, with worldwide sales exceeding $5.5 billion in 2012. ED affects an estimated 52 percent of men between the ages of 40 and 70. Prevalence increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists); lifestyle (tobacco, alcohol use); diseases (diabetes, cardiovascular conditions, prostate cancer); prostatectomy, and spinal cord injuries. Left untreated, ED can negatively impact relationships and self-esteem, causing feelings of embarrassment and guilt. However, about half of men being treated with currently available PDE5 inhibitors are dissatisfied with the results of that treatment. "The recommendations for use of current PDE5 inhibitors instruct patients to take the medication and wait one to two hours prior to sexual activity or to take the medication daily," said Peter Tam, president of VIVUS, Inc. "Having a shorter waiting time prior to sexual activity in the label, if approved, would provide STENDRA a differentiated profile that is desired by many patients and prescribers." "We intend to file for an amendment to both the FDA approval and the pending EMA application to include the results of this study and appropriate new labeling. If approved, STENDRA, and SPEDRA, as it is known in the European Union, will have the unique advantage of being the only PDE5 inhibitor to be able to make this claim," stated Wesley W. Day, Ph.D., vice president, clinical development of VIVUS, Inc. The study protocol and statistical analysis plan were approved by the FDA. The study randomized 440 patients with mild to severe ED and was conducted at 30 sites in the United States. The study included both diabetic and non-diabetic patients. The average age of men in the study was 58, most of which had previously used other ED therapy. The design required patients to use a stopwatch to record the timing of sexual activity. The most common drug-related side effects were headache and nasal congestion. There were no drug-related serious adverse events reported in the studies. The study results will be included in an amendment to the Stendra NDA, submitted to upcoming medical society meetings, and shared in ongoing partnership discussions.