VIVUS Avanafil phase 3 trial on erectile dysfunction meets primary endpoints

VIVUS, Inc.Jun 17 2011

VIVUS, Inc. (Nasdaq: VVUS) today announced that the positive results from REVIVE-RP (TA-303), a phase 3 clinical trial evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED),will be presented this afternoon at the 2011 Cancer Survivorship and Sexual Health Symposium in Washington D.C.  The meeting is jointly sponsored by the International Society for Sexual Medicine (ISSM) and the Sexual Medicine Society of North America (SMSNA).  John Mulhall, M.D., Director of the Male Sexual & Reproductive Medicine Program at the Memorial Sloan Kettering Cancer Center in New York, will present the results during the peer-reviewed, moderated poster session.  

Avanafil met all primary endpoints by demonstrating improvements from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP 2 and SEP 3) and improvement in the erectile function domain of International Index of Erectile Function (IIEF).  The study also indicated a favorable safety profile and successful intercourse (as measured by SEP 3) was observed as early as 15 minutes after dosing, without any restrictions on food or alcohol.

"Patients who have undergone a radical prostatectomy (RP) often have severe erectile dysfunction.  Despite advancements in surgery, it can take several months or years to normalize erections.  RP 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 for these patients," commented Dr. Mulhall.  "I am pleased to be presenting these positive results with the health professionals attending the Cancer Survivorship Meeting.  The safety and efficacy demonstrated in this trial may offer hope to patients who have been unable to return to normal erectile function following their surgery."

Highlights of the TA-303 study include:

• Treatment with both doses of avanafil (100 mg and 200 mg) was associated with significant improvements in each of the co-primary endpoints, SEP2, SEP3 and IIEF-EF in comparison with placebo (p <0.001)
• Patients treated with 100 mg and 200 mg of avanafil improved their ability to have successful intercourse (SEP3) four- and five-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 38% and 55% for patients on the 100 mg and 200 mg doses, respectively, as compared to the placebo group with an increase of 1%
• The most commonly reported side effects in patients taking avanafil included headache, flushing, and nasopharyngitis
• There were no serious adverse events or deaths reported in the study