VIVUS (VVUS) Gets EMA Acceptance of Avanafil Marketing App

VIVUS,Inc. (Nasdaq: VVUS) reports that a Marketing Authorization Application (MAA) has been accepted by the European Medicines Agency (EMA) for the review of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The EMA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients.

The MAA includes results from three placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, REVIVE-Diabetes, which included 390 diabetics, and REVIVE-RP, which included 298 men following radical prostatectomy. Also included are the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies. Previously reported highlights from the avanafil development program include:

• All doses tested , 50 mg, 100 mg, and 200 mg, met each of the co-primary efficacy endpoints
  
  
• Erections sufficient for penetration (SEP2) were observed in 77% and 63% of avanafil patients at the 200 mg dose, as compared to 54% and 42% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively
  
  
• Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients at the 200 mg dose, as compared to 27% and 20% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively
  
  
• Significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients
  
  
• Across all the phase 3 studies, successful intercourse (SEP3) was observed in some avanafil-treated patients as early as 15 minutes after dosing
  
  
• The most common side effects were headache, flushing, nasopharyngitis and nasal congestion
  
  
• There were no drug-related serious adverse events reported in the studies

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